Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-21 @ 1:20 AM
Study NCT ID:
NCT03141567
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2017-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LYmphangiogenesis FacTors in Heart Failure States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma or serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular Endothelial Growth Factor (VEGF) Levels', 'timeFrame': 'At time of right heart catheterization', 'description': 'VEGF levels in systemic venous, pulmonary arterial, and pulmonary venous samples in participants with left heart failure versus those without left heart failure.'}], 'secondaryOutcomes': [{'measure': 'Lymphangiogenesis factors and Pulmonary Capillary Wedge Pressure (PCWP)', 'timeFrame': 'At time of right heart catheterization', 'description': 'Correlation between above lymphangiogenesis factors and pulmonary capillary wedge pressure, right atrial pressure, and cardiac output gathered from right heart catheterization.'}, {'measure': 'Lymphangiogenesis and Heart failure severity', 'timeFrame': 'At time of right heart catheterization', 'description': 'Correlation between lymphangiogenesis factors and heart failure symptom severity as determined by the Kansas City Cardiomyopathy Questionnaire'}, {'measure': 'Lymphangiogenesis and 6 minute hall walk', 'timeFrame': 'At time of right heart catheterization', 'description': 'Correlation between lymphangiogenesis factors and 6 minute walk distance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphangiogenesis', 'Heart Failure'], 'conditions': ['Heart Failure', 'Heart Failure With Reduced Ejection Fraction', 'Heart Failure With Normal Ejection Fraction']}, 'descriptionModule': {'briefSummary': 'Heart failure often causes fluid to accumulate in the body, leading to congestion and swelling. However, some people who have had heart failure for a long time seem to have very little congestion or swelling, even when the heart failure is poorly treated. The investigators think that this is because lymphatic vessels are able to grow and remove fluid to prevent congestion. The investigators do not know how lymphatic vessels grow. This study will investigate the blood levels of various proteins to try to figure out how the lymph vessels of people with long-standing heart failure might grow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Inpatient and Outpatient individuals undergoing clincially-indicated right heart catheterization.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Undergoing clinically indicated right heart catheterization.\n\nExclusion Criteria:\n\n* Unable to provide consent.\n* Use of medications which may alter lymphangiogenesis factor expression within 365 days\n* Thalidomide, lenalidomide, pomalidomide\n* Bevacizumab\n* Any cytotoxic chemotherapy agents\n* Pregnant\n* Any potentially pregnant patient (based on age and gender) undergoes Beta Human chorionic gonadotropin testing as standard of care prior to any right heart catheterization.\n* Active cancer within 365 days\n* Diagnosis of familial or secondary lymphedema\n* Treatment of active bacterial infection within 7 days\n* Active inflammatory rheumatologic disease requiring anti-inflammatory therapy administration within 60 days\n* Conditions\n* Systemic lupus erythematosus\n* Rheumatoid arthritis\n* Scleroderma\n* Inflammatory myositis\n* Vasculitis\n* Behcet's disease"}, 'identificationModule': {'nctId': 'NCT03141567', 'acronym': 'LYFT-HF', 'briefTitle': 'LYmphangiogenesis FacTors in Heart Failure States', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'LYmphangiogenesis FacTors in Heart Failure States (LYFT-HF Study)', 'orgStudyIdInfo': {'id': 'Pro00062457'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Outpatient', 'description': 'Individuals undergoing clinically indicated Right Heart Catheterization.'}, {'label': 'Inpatient', 'description': 'Individuals undergoing clinically indicated Right Heart Catheterization.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VAMC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Brian Houston, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}