Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 7:54 PM
Study NCT ID:
NCT01306292
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2011-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of SonoVue on Pulmonary Hemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C420843', 'term': 'contrast agent BR1'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marialuigia.storto@diag.bracco.com', 'phone': '609-514-2262', 'title': 'Dr. Maria Luigia Storto', 'organization': 'Bracco Diagnostics Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were to be monitored from the time of signed informed consent until 24 hours after the last investigational product administration.', 'eventGroups': [{'id': 'EG000', 'title': 'Hypertension Group', 'description': 'Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.', 'otherNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Pulmonary Pressure Group', 'description': 'Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure \\<25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.', 'otherNumAtRisk': 18, 'otherNumAffected': 2, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertension Placebo', 'description': 'Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'OG001', 'title': 'Hypertension SonoVue', 'description': 'Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'OG002', 'title': 'Normal Placebo', 'description': 'Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure \\< 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'OG003', 'title': 'Normal SonoVue', 'description': 'Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure \\< 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.'}], 'classes': [{'title': 'Baseline Systolic PAP (mmHg)', 'categories': [{'measurements': [{'value': '50.50', 'spread': '17.581', 'groupId': 'OG000'}, {'value': '50.50', 'spread': '17.581', 'groupId': 'OG001'}, {'value': '30.08', 'spread': '6.001', 'groupId': 'OG002'}, {'value': '30.08', 'spread': '6.001', 'groupId': 'OG003'}]}]}, {'title': '1 minute post-dose', 'categories': [{'measurements': [{'value': '-2.17', 'spread': '5.993', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '5.407', 'groupId': 'OG001'}, {'value': '1.31', 'spread': '3.214', 'groupId': 'OG002'}, {'value': '0.47', 'spread': '2.464', 'groupId': 'OG003'}]}]}, {'title': '4 minutes post-dose', 'categories': [{'measurements': [{'value': '-3.06', 'spread': '5.196', 'groupId': 'OG000'}, {'value': '-2.94', 'spread': '5.352', 'groupId': 'OG001'}, {'value': '1.50', 'spread': '4.345', 'groupId': 'OG002'}, {'value': '0.62', 'spread': '2.485', 'groupId': 'OG003'}]}]}, {'title': '7 minutes post-dose', 'categories': [{'measurements': [{'value': '-1.94', 'spread': '6.010', 'groupId': 'OG000'}, {'value': '-2.28', 'spread': '4.854', 'groupId': 'OG001'}, {'value': '0.86', 'spread': '3.940', 'groupId': 'OG002'}, {'value': '-0.32', 'spread': '2.215', 'groupId': 'OG003'}]}]}, {'title': '10 minutes post-dose', 'categories': [{'measurements': [{'value': '-2.44', 'spread': '6.849', 'groupId': 'OG000'}, {'value': '-2.17', 'spread': '5.300', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '4.816', 'groupId': 'OG002'}, {'value': '-0.69', 'spread': '3.945', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)', 'description': 'A total of 36 subjects were enrolled in this crossover study: 18 (8 randomized to placebo then SonoVue and 10 randomized to SonoVue then placebo) in the Hypertension Group (baseline mean pulmonary artery pressure (PAP) \\>=25.0 mmHg group) and 18 (10 randomized to placebo then SonoVue and 8 randomized to SonoVue then placebo) in the Normal group (baseline mean PAP \\<25.0 mmHg group). All subjects in this study were to have systolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in systolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP \\>=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP \\<25.0 mmHg group (Normal Group).'}, {'type': 'PRIMARY', 'title': 'Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertension Placebo', 'description': 'Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'OG001', 'title': 'Hypertension SonoVue', 'description': 'Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'OG002', 'title': 'Normal Placebo', 'description': 'Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure \\< 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'OG003', 'title': 'Normal SonoVue', 'description': 'Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure \\< 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.'}], 'classes': [{'title': 'Baseline Diastolic PAP (mmHg)', 'categories': [{'measurements': [{'value': '24.11', 'spread': '7.177', 'groupId': 'OG000'}, {'value': '24.11', 'spread': '7.177', 'groupId': 'OG001'}, {'value': '11.72', 'spread': '3.750', 'groupId': 'OG002'}, {'value': '11.72', 'spread': '3.750', 'groupId': 'OG003'}]}]}, {'title': '1 minute post-dose', 'categories': [{'measurements': [{'value': '-3.39', 'spread': '4.661', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '3.884', 'groupId': 'OG001'}, {'value': '1.44', 'spread': '3.481', 'groupId': 'OG002'}, {'value': '1.22', 'spread': '4.156', 'groupId': 'OG003'}]}]}, {'title': '4 minutes post-dose', 'categories': [{'measurements': [{'value': '-3.56', 'spread': '4.362', 'groupId': 'OG000'}, {'value': '-2.78', 'spread': '6.839', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '3.508', 'groupId': 'OG002'}, {'value': '0.68', 'spread': '2.767', 'groupId': 'OG003'}]}]}, {'title': '7 minutes post-dose', 'categories': [{'measurements': [{'value': '-3.22', 'spread': '5.342', 'groupId': 'OG000'}, {'value': '-3.06', 'spread': '4.325', 'groupId': 'OG001'}, {'value': '1.61', 'spread': '2.471', 'groupId': 'OG002'}, {'value': '1.09', 'spread': '3.104', 'groupId': 'OG003'}]}]}, {'title': '10 minutes post-dose', 'categories': [{'measurements': [{'value': '-3.44', 'spread': '5.731', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '4.836', 'groupId': 'OG001'}, {'value': '1.39', 'spread': '2.207', 'groupId': 'OG002'}, {'value': '0.78', 'spread': '3.723', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)', 'description': 'All subjects in this study were to have diastolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in diastolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP \\>=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP \\<25.0 mmHg group (Normal Group).'}, {'type': 'PRIMARY', 'title': 'Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertension Placebo', 'description': 'Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'OG001', 'title': 'Hypertension SonoVue', 'description': 'Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'OG002', 'title': 'Normal Placebo', 'description': 'Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure \\< 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'OG003', 'title': 'Normal SonoVue', 'description': 'Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure \\< 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.'}], 'classes': [{'title': 'Baseline PVR (dyne*sec/cm^5)', 'categories': [{'measurements': [{'value': '307.189', 'spread': '307.6268', 'groupId': 'OG000'}, {'value': '307.189', 'spread': '307.6268', 'groupId': 'OG001'}, {'value': '142.714', 'spread': '93.6055', 'groupId': 'OG002'}, {'value': '142.714', 'spread': '93.6055', 'groupId': 'OG003'}]}]}, {'title': '1 minute post-dose', 'categories': [{'measurements': [{'value': '-73.087', 'spread': '186.9939', 'groupId': 'OG000'}, {'value': '-63.065', 'spread': '158.7097', 'groupId': 'OG001'}, {'value': '20.541', 'spread': '63.4305', 'groupId': 'OG002'}, {'value': '1.021', 'spread': '55.5296', 'groupId': 'OG003'}]}]}, {'title': '10 minutes post-dose', 'categories': [{'measurements': [{'value': '-41.468', 'spread': '226.7863', 'groupId': 'OG000'}, {'value': '-10.028', 'spread': '175.0397', 'groupId': 'OG001'}, {'value': '21.208', 'spread': '82.9967', 'groupId': 'OG002'}, {'value': '-6.117', 'spread': '52.0617', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose)', 'description': 'All subjects in this study were to have pulmonary vascular resistance (PVR; measured in dyne x seconds per centimeters to the 5th power) derived from mean PAP (measured in mmHg), pulmonary capillary wedge pressure (PCWP \\[mmHg\\]) and cardiac output (Qp \\[litres per minute\\]), each taken 5 minutes prior to the first investigational product administration, calculated using the following formula: \\[(mean PAP-PCWP) divided by Qp\\] x 80. Baseline is the last measurement prior to first investigational product administration, therefore, applying to both products. Mean PAP, PCWP and Qp were repeated at 1 and 10 minutes post dose; PVR was calculated.', 'unitOfMeasure': 'dyne*sec/cm^5', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP \\>=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP \\<25.0 mmHg group (Normal Group).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hypertension Group (SonoVue First, Then Placebo)', 'description': 'Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.'}, {'id': 'FG001', 'title': 'Hypertension Group (Placebo First, Then SonoVue)', 'description': 'Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.'}, {'id': 'FG002', 'title': 'Normal Group (SonoVue First, Then Placebo)', 'description': 'Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure \\<25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.'}, {'id': 'FG003', 'title': 'Normal Group (Placebo First, Then SonoVue)', 'description': 'Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure \\<25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.'}], 'periods': [{'title': 'First Injection', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout (at Least 10 Minutes)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Second Injection', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'comment': '1 subject completed both injections but not 24-hour follow-up; all other values were recorded.', 'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hypertension Group', 'description': 'Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'BG001', 'title': 'Normal Group', 'description': 'Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure \\<25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '12.96', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '10.70', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '11.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2012-12-07', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2011-02-23', 'dispFirstSubmitQcDate': '2012-12-07', 'resultsFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2011-02-28', 'dispFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-11', 'studyFirstPostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline', 'timeFrame': 'Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)', 'description': 'A total of 36 subjects were enrolled in this crossover study: 18 (8 randomized to placebo then SonoVue and 10 randomized to SonoVue then placebo) in the Hypertension Group (baseline mean pulmonary artery pressure (PAP) \\>=25.0 mmHg group) and 18 (10 randomized to placebo then SonoVue and 8 randomized to SonoVue then placebo) in the Normal group (baseline mean PAP \\<25.0 mmHg group). All subjects in this study were to have systolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in systolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.'}, {'measure': 'Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline', 'timeFrame': 'Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)', 'description': 'All subjects in this study were to have diastolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in diastolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.'}, {'measure': 'Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline', 'timeFrame': 'Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose)', 'description': 'All subjects in this study were to have pulmonary vascular resistance (PVR; measured in dyne x seconds per centimeters to the 5th power) derived from mean PAP (measured in mmHg), pulmonary capillary wedge pressure (PCWP \\[mmHg\\]) and cardiac output (Qp \\[litres per minute\\]), each taken 5 minutes prior to the first investigational product administration, calculated using the following formula: \\[(mean PAP-PCWP) divided by Qp\\] x 80. Baseline is the last measurement prior to first investigational product administration, therefore, applying to both products. Mean PAP, PCWP and Qp were repeated at 1 and 10 minutes post dose; PVR was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary hypertension', 'Right heart Catheterization'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'This is an intra-subject crossover comparative safety study to evaluate the effect of intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.', 'detailedDescription': 'Subjects will be divided into two groups based on their baseline mean pulmonary arterial pressure. Each subject will receive two injections in randomized order during right heart catheterization: one administration of SonoVue and one administration of placebo, either SonoVue followed by Placebo or Placebo followed by SonoVue. The purpose is to provide direct evidence on the presence or absence of pulmonary hemodynamic effect following IV administration of SonoVue versus any effects following IV administration of the same volume of placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provides written informed consent male or female at least 18 years of age scheduled to undergo right heart catheterization for clinical reasons\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Significant arrhythmia or non-sinus rhythm that may affect the ability to assess pulmonary hemodynamics by catheterization\n* Known allergy to one of the ingredients in the investigational product or to any other contrast agents including ultrasound contrast agents\n* Previously entered into the study or received an investigational compound within 30 days before admission into the study\n* Unstable pulmonary and/or systemic hemodynamic condition that would affect the ability to evaluate the pharmacological or hemodynamic effect of the investigational products'}, 'identificationModule': {'nctId': 'NCT01306292', 'briefTitle': 'Safety of SonoVue on Pulmonary Hemodynamics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bracco Diagnostics, Inc'}, 'officialTitle': 'A Phase II, Double-Blind, Randomized, Placebo-Controlled, Crossover, Safety Study of the Effect of Intravenous Bolus Injections of SonoVue on Pulmonary Hemodynamics in Subjects With and Without Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'BR1-133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SonoVue', 'description': 'Ultrasound contrast agent under development', 'interventionNames': ['Drug: SonoVue']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'normal saline 0.9% for injection used as the comparator', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SonoVue', 'type': 'DRUG', 'otherNames': ['sulfur hexafluoride microbubbles', 'sulfur hexafluoride lipid-type A microspheres'], 'description': 'dose of 4.8 mL administered intravenously one time', 'armGroupLabels': ['SonoVue']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'description': 'Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Holy Name Medical Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}], 'overallOfficials': [{'name': 'Maria Luigia Storto, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bracco Diagnostics, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Study of Lumason pulmonary hemodynamics'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bracco Diagnostics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}