Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-20 @ 7:24 PM
Study NCT ID:
NCT03696758
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2018-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Right Ventricular Function in Young Adults Born Preterm
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kara.goss@utsouthwestern.edu', 'phone': '214-648-6868', 'title': 'Dr. Kara Goss', 'organization': 'UT Southwestern, Dallas, Texas'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Sildenafil Followed by Metoprolol', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metoprolol Followed by Sildenafil', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given metoprolol in between imaging scans at one visit, and will receive intravenous sildenafil in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Right Ventricular Energetic Efficiency Pre and Post Metoprolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart Metoprolol: Subjects will receive intravenous metoprolol Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre Metoprolol', 'categories': [{'measurements': [{'value': '15.5', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Post Metoprolol', 'categories': [{'measurements': [{'value': '12.7', 'spread': '2.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000'], 'pValueComment': "p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'To characterize energy efficiency, the total Kinetic Energy across the cardiac cycle is normalized to right ventricular end-diastolic volume and left ventricular end-diastolic volume, respectively. Analysis will be completed in blinded fashion. Two imaging scans will be done - one pre and one post Metoprolol intervention. Total time from Pre-intervention scan till post intervention scan may take up to 2 hours.', 'unitOfMeasure': 'µJ/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Right Ventricular Energetic Efficiency Pre and Post Sildenafil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart Metoprolol: Subjects will receive intravenous metoprolol Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Sildenafil', 'categories': [{'measurements': [{'value': '15.8', 'spread': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Post-Sildenafil', 'categories': [{'measurements': [{'value': '17.9', 'spread': '6.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'To characterize energy efficiency, the total Kinetic Energy across the cardiac cycle is normalized to right ventricular end-diastolic volume and left ventricular end-diastolic volume, respectively. Analysis will be completed in blinded fashion. Two imaging scans will be done - one pre and one post Sildenafil intervention. Total time from Pre-intervention scan till post intervention scan may take up to 2 hours.', 'unitOfMeasure': 'µJ/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Energetic Efficiency Pre and Post Metoprolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Metoprolol', 'categories': [{'measurements': [{'value': '11.6', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': 'Post-Metoprolol', 'categories': [{'measurements': [{'value': '9.5', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000'], 'pValueComment': "p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will receive intravenous metoprolol in between scans.', 'unitOfMeasure': 'µJ/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Right Ventricular Ejection Fraction Pre and Post Metoprolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Metoprolol', 'categories': [{'measurements': [{'value': '55', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': 'Post-Metoprolol', 'categories': [{'measurements': [{'value': '51', 'spread': '8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.1', 'groupIds': ['OG000'], 'pValueComment': "p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Right Ventricular Stroke Volume Pre and Post Metoprolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Metoprolol', 'categories': [{'measurements': [{'value': '41.5', 'spread': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'Post-Metoprolol', 'categories': [{'measurements': [{'value': '37.7', 'spread': '5.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000'], 'pValueComment': "p value is 0.09 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Right Ventricular Systolic Volume Pre and Post Metoprolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Metoprolol', 'categories': [{'measurements': [{'value': '33.7', 'spread': '7.5', 'groupId': 'OG000'}]}]}, {'title': 'Post-Metoprolol', 'categories': [{'measurements': [{'value': '36.6', 'spread': '9.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000'], 'pValueComment': "p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Right Ventricular Diastolic Volume Pre and Post Metoprolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Metoprolol', 'categories': [{'measurements': [{'value': '75.2', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Post-Metoprolol', 'categories': [{'measurements': [{'value': '74.4', 'spread': '9.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000'], 'pValueComment': "p value is 0.82 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction Pre and Post Metoprolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Metoprolol', 'categories': [{'measurements': [{'value': '60', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': 'Post-Metoprolol', 'categories': [{'measurements': [{'value': '58', 'spread': '8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000'], 'pValueComment': "p value is 0.30 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Stroke Volume Pre and Post Metoprolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Metoprolol', 'categories': [{'measurements': [{'value': '43.7', 'spread': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Post-Metoprolol', 'categories': [{'measurements': [{'value': '41.4', 'spread': '5.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000'], 'pValueComment': "p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Systolic Volume Pre and Post Metoprolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Metoprolol', 'categories': [{'measurements': [{'value': '28.8', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': 'Post-Metoprolol', 'categories': [{'measurements': [{'value': '30.6', 'spread': '8.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000'], 'pValueComment': "p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Diastolic Volume Pre and Post Metoprolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Metoprolol', 'categories': [{'measurements': [{'value': '72.5', 'spread': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Post-Metoprolol', 'categories': [{'measurements': [{'value': '72.1', 'spread': '9.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.65 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Energetic Efficiency Pre and Post Sildenafil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Sildenafil', 'categories': [{'measurements': [{'value': '11.1', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Post-Sildenafil', 'categories': [{'measurements': [{'value': '12.3', 'spread': '4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will be given sildenafil in between imaging scans.', 'unitOfMeasure': 'µJ/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Right Ventricular Ejection Fraction Pre and Post Sildenafil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Sildenafil', 'categories': [{'measurements': [{'value': '53', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Post-Sildenafil', 'categories': [{'measurements': [{'value': '55', 'spread': '10', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.43 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans. The term "ejection fraction" refers to the percentage of blood that\'s pumped out of a filled ventricle with each heartbeat.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Right Ventricular Stroke Volume Pre and Post Sildenafil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Sildenafil', 'categories': [{'measurements': [{'value': '40.4', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Post-Sildenafil', 'categories': [{'measurements': [{'value': '41.3', 'spread': '10.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.66 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Right Ventricular Systolic Volume Pre and Post Sildenafil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Sildenafil', 'categories': [{'measurements': [{'value': '35.8', 'spread': '8.5', 'groupId': 'OG000'}]}]}, {'title': 'Post-Sildenafil', 'categories': [{'measurements': [{'value': '33.3', 'spread': '7.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Right Ventricular Diastolic Volume Pre and Post Sildenafil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Sildenafil', 'categories': [{'measurements': [{'value': '76.2', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Post-Sildenafil', 'categories': [{'measurements': [{'value': '74.6', 'spread': '11.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.57 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction Pre and Post Sildenafil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Sildenafil', 'categories': [{'measurements': [{'value': '60', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Post-Sildenafil', 'categories': [{'measurements': [{'value': '63', 'spread': '8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Stroke Volume Pre and Post Sildenafil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Sildenafil', 'categories': [{'measurements': [{'value': '43.1', 'spread': '8.1', 'groupId': 'OG000'}]}]}, {'title': 'Post-Sildenafil', 'categories': [{'measurements': [{'value': '45.7', 'spread': '9.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.07 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Systolic Volume Pre and Post Sildenafil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Sildenafil', 'categories': [{'measurements': [{'value': '28.1', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Post-Sildenafil', 'categories': [{'measurements': [{'value': '26.6', 'spread': '5.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.36 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Diastolic Volume Pre and Post Sildenafil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm\n\nCardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart\n\nMetoprolol: Subjects will receive intravenous metoprolol\n\nSildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'classes': [{'title': 'Pre-Sildenafil', 'categories': [{'measurements': [{'value': '71.2', 'spread': '8.8', 'groupId': 'OG000'}]}]}, {'title': 'Post-Sildenafil', 'categories': [{'measurements': [{'value': '72.2', 'spread': '8.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000'], 'pValueComment': "P-Value is 0.91 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup", 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sildenafil Followed by Metoprolol', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.'}, {'id': 'FG001', 'title': 'Metoprolol Followed by Sildenafil', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given metoprolol in between imaging scans at one visit, and will receive intravenous sildenafil in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Wash Out>12 Hours', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Due to COVID shut down, 1 participant was excluded from the study before assignment to groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Young Adults Born Premature', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram.\n\nPulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity.\n\nElectrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart Metoprolol: Subjects will receive intravenous metoprolol Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '3.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational age (Neonatal Characteristics)', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '2.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Birth weight (Neonatal Characteristics)', 'classes': [{'categories': [{'measurements': [{'value': '1116', 'spread': '342', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'gram', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-30', 'size': 578557, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-13T13:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-24', 'studyFirstSubmitDate': '2018-10-03', 'resultsFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2018-10-03', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-22', 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Right Ventricular Energetic Efficiency Pre and Post Metoprolol', 'timeFrame': 'up to 2 hours', 'description': 'To characterize energy efficiency, the total Kinetic Energy across the cardiac cycle is normalized to right ventricular end-diastolic volume and left ventricular end-diastolic volume, respectively. Analysis will be completed in blinded fashion. Two imaging scans will be done - one pre and one post Metoprolol intervention. Total time from Pre-intervention scan till post intervention scan may take up to 2 hours.'}, {'measure': 'Right Ventricular Energetic Efficiency Pre and Post Sildenafil', 'timeFrame': 'up to 2 hours', 'description': 'To characterize energy efficiency, the total Kinetic Energy across the cardiac cycle is normalized to right ventricular end-diastolic volume and left ventricular end-diastolic volume, respectively. Analysis will be completed in blinded fashion. Two imaging scans will be done - one pre and one post Sildenafil intervention. Total time from Pre-intervention scan till post intervention scan may take up to 2 hours.'}], 'secondaryOutcomes': [{'measure': 'Left Ventricular Energetic Efficiency Pre and Post Metoprolol', 'timeFrame': 'up to 2 hours', 'description': 'Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will receive intravenous metoprolol in between scans.'}, {'measure': 'Right Ventricular Ejection Fraction Pre and Post Metoprolol', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.'}, {'measure': 'Right Ventricular Stroke Volume Pre and Post Metoprolol', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.'}, {'measure': 'Right Ventricular Systolic Volume Pre and Post Metoprolol', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.'}, {'measure': 'Right Ventricular Diastolic Volume Pre and Post Metoprolol', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.'}, {'measure': 'Left Ventricular Ejection Fraction Pre and Post Metoprolol', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.'}, {'measure': 'Left Ventricular Stroke Volume Pre and Post Metoprolol', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.'}, {'measure': 'Left Ventricular Systolic Volume Pre and Post Metoprolol', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.'}, {'measure': 'Left Ventricular Diastolic Volume Pre and Post Metoprolol', 'timeFrame': 'up to 2 hours', 'description': 'Participants will receive intravenous metoprolol in between scans.'}, {'measure': 'Left Ventricular Energetic Efficiency Pre and Post Sildenafil', 'timeFrame': 'up to 2 hours', 'description': 'Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will be given sildenafil in between imaging scans.'}, {'measure': 'Right Ventricular Ejection Fraction Pre and Post Sildenafil', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans. The term "ejection fraction" refers to the percentage of blood that\'s pumped out of a filled ventricle with each heartbeat.'}, {'measure': 'Right Ventricular Stroke Volume Pre and Post Sildenafil', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.'}, {'measure': 'Right Ventricular Systolic Volume Pre and Post Sildenafil', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.'}, {'measure': 'Right Ventricular Diastolic Volume Pre and Post Sildenafil', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.'}, {'measure': 'Left Ventricular Ejection Fraction Pre and Post Sildenafil', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.'}, {'measure': 'Left Ventricular Stroke Volume Pre and Post Sildenafil', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.'}, {'measure': 'Left Ventricular Systolic Volume Pre and Post Sildenafil', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.'}, {'measure': 'Left Ventricular Diastolic Volume Pre and Post Sildenafil', 'timeFrame': 'up to 2 hours', 'description': 'Participants will be given sildenafil in between imaging scans.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['premature adults', 'premature', 'premature cardiac function', 'MRI', 'sildenafil', 'metoprolol', 'CMR'], 'conditions': ['Infant,Premature']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to evaluate the short-term effects of sildenafil and metoprolol on heart function in young adults born premature.', 'detailedDescription': 'The purpose of this study is to evaluate the short-term therapeutic effects of sildenafil and metoprolol on right ventricular function in young adults born premature using novel 4-Dimensional flow Cardiac Magnetic Resonance Imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Male or female aged 18-35\n3. History of preterm birth (either a or b):\n\n 1. Participant in the Newborn Lung Project (birth year 1988-1991, birth weight \\<1500 g)\n 2. Non-NLP participant, with birth weight \\<1500 g and gestational age 32 weeks or less, verified by medical records\n\nExclusion Criteria:\n\n1. Pregnant or lactating\n2. Use of prescribed medications that would interfere with study medications\n\n 1. Sildenafil: Use of phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil), nitrates, soluble guanylate cyclase inhibitor (riociguat) within 48 hours of study visit\n 2. Metoprolol: Use of nodal blocking agents including beta blockers, non-dihydropyridine calcium channel blockers (i.e. diltiazem), and anti-arrhythmics (i.e. amiodarone)\n3. Presence of known comorbidities for which these therapeutic interventions would be contraindicated:\n\n 1. Moderate to severe heart failure\n 2. Severe bradycardia (heart rate \\<45), or second or third-degree heart block\n 3. Systolic blood pressure \\<90 mmHg or \\>190 mmHg\n 4. Angina\n 5. Severe peripheral arterial circulatory disorders\n 6. History of severe bronchospasm\n4. Presence of any implanted device incompatible with CMR imaging\n5. Known allergic or hypersensitivity reaction to components of the study medications\n6. Any other reason for which the investigator deems a subject unsafe or inappropriate for study participation.'}, 'identificationModule': {'nctId': 'NCT03696758', 'briefTitle': 'Improving Right Ventricular Function in Young Adults Born Preterm', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Improving Right Ventricular Function in Young Adults Born Preterm: A Pilot Study', 'orgStudyIdInfo': {'id': '2018-0796'}, 'secondaryIdInfos': [{'id': '1UL1TR002373-01', 'link': 'https://reporter.nih.gov/quickSearch/1UL1TR002373-01', 'type': 'NIH'}, {'id': 'A534285', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/MEDICINE/PULMON MED', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 8/30/2018', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sildenafil followed by Metoprolol', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.', 'interventionNames': ['Procedure: Pulmonary Function Testing', 'Procedure: Electrocardiogram', 'Procedure: Cardiac Magnetic Resonance Imaging', 'Drug: Metoprolol', 'Drug: Sildenafil']}, {'type': 'EXPERIMENTAL', 'label': 'Metoprolol followed by Sildenafil', 'description': 'Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given metoprolol in between imaging scans at one visit, and will receive intravenous sildenafil in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.', 'interventionNames': ['Procedure: Pulmonary Function Testing', 'Procedure: Electrocardiogram', 'Procedure: Cardiac Magnetic Resonance Imaging', 'Drug: Metoprolol', 'Drug: Sildenafil']}], 'interventions': [{'name': 'Pulmonary Function Testing', 'type': 'PROCEDURE', 'description': 'Subjects will undergo spirometry, Plethysmography, and diffusion capacity.', 'armGroupLabels': ['Metoprolol followed by Sildenafil', 'Sildenafil followed by Metoprolol']}, {'name': 'Electrocardiogram', 'type': 'PROCEDURE', 'description': 'Subjects will undergo an electrocardiogram to ensure sinus rhythm', 'armGroupLabels': ['Metoprolol followed by Sildenafil', 'Sildenafil followed by Metoprolol']}, {'name': 'Cardiac Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'description': 'Subjects will undergo positron magnetic resonance imaging to detect images of the heart', 'armGroupLabels': ['Metoprolol followed by Sildenafil', 'Sildenafil followed by Metoprolol']}, {'name': 'Metoprolol', 'type': 'DRUG', 'otherNames': ['Lopressor', 'Metolar XR'], 'description': 'Subjects will receive intravenous metoprolol. Dose titrated 1-5 mg every 2 minutes to achieve goal heart rate of 55-65 beats per minute, or for subjects with a resting heart rate already at goal, titrated to achieve a 10-15% reduction in heart rate.', 'armGroupLabels': ['Metoprolol followed by Sildenafil', 'Sildenafil followed by Metoprolol']}, {'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Revatio'], 'description': 'Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)', 'armGroupLabels': ['Metoprolol followed by Sildenafil', 'Sildenafil followed by Metoprolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Kara N Goss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin-Madison School of Medicine and Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}