Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT04702958
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2021-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TRANSFORM-HF Ancillary Mechanistic Study
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_WITHOUT_DNA', 'description': '* Single biomarkers: high sensitive cardiac troponin T (hs-cTnT), amino terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor 15 (GDF-15), Cystatin C, high sensitive C-reactive protein (hsCRP), and interleukin 6 (IL6).\n* Urinary biomarkers: albumin, beta-2 microglobulin (B2M), cystatin C, epidermal growth factor (EGF), neutrophil gelatinase-associated lipocalin (NGAL/Lipocalin-2), osteopontin (OPN), uromodulin (UMOD)\n* Targeted discovery proteomics: Olink CARDIOVASCULAR III (CVD III) panel\n* Covid-19 antibodies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in proteomic protein clusters between treatment groups', 'timeFrame': 'baseline', 'description': 'How the biomarkers are different between groups'}, {'measure': 'Differences in trajectories of protein clusters between treatment groups', 'timeFrame': '90 days', 'description': 'How the protein clusters change over time from baseline to 90 days'}], 'secondaryOutcomes': [{'measure': 'Differences in single biomarkers and biomarker trajectories between treatment groups', 'timeFrame': 'baseline and 90 days', 'description': 'How the biomarkers are different between groups at baseline and how the biomarkers change over time from baseline to 90 days'}, {'measure': 'Differences in urinary protein levels between treatment groups', 'timeFrame': 'baseline', 'description': 'How the in urinary protein levels are different between patient prescribed Torsemide vs Furosemide'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Patients with heart failure are frequently treated with diuretics, including furosemide and torsemide, but it is not known if one is better than the other. The TRANSFORM-HF trial is studying if torsemide is superior than furosemide for reducing the endpoint of death or hospitalization, but is not designed to study why. This ancillary study seeks to measure proteins in the blood and urine to help explain the underlying mechanism for why patients who take one of these diuretics may have better outcomes than patients who take the other.', 'detailedDescription': 'Patients who are enrolling in the TRANSFORM-HF study or being prescribed Torsemide or Furosemide at hospital discharge will provide blood and urine at the time of study enrollment (within 72 hours of hospital discharge) and at 90 days (+/- one week) after hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll a subset of patients who are enrolling in the TRANSFORM-HF study during a hospitalization for acute HF, or who are prescribed Torsemide or Furosemide at hospital discharge, and who are willing to provide biospecimens for analysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in the TRANSFORM-HF trial or prescription of Torsemide or Furosemide\n* Willing to provide blood and urine sample at enrollment and follow-up\n\nExclusion Criteria:\n\n* Inability or unwillingness to comply with the study requirements'}, 'identificationModule': {'nctId': 'NCT04702958', 'briefTitle': 'TRANSFORM-HF Ancillary Mechanistic Study', 'organization': {'class': 'OTHER', 'fullName': 'Inova Health Care Services'}, 'officialTitle': 'Mechanistic Insights From Longitudinal Changes in Blood and Urine Proteins to Explain Efficacy and Safety of Torsemide vs Furosemide After a Heart Failure Hospitalization', 'orgStudyIdInfo': {'id': 'R01HL154768-01', 'link': 'https://reporter.nih.gov/quickSearch/R01HL154768-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01HL154768-01', 'link': 'https://reporter.nih.gov/quickSearch/R01HL154768-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Torsemide', 'description': 'Patients enrolled in the TRANSFORM-HF study randomized to Torsemide, or patients prescribed Torsemide at hospital discharge'}, {'label': 'Furosemide', 'description': 'Patients enrolled in the TRANSFORM-HF study randomized to Furosemide, or patients prescribed Furosemide at hospital discharge'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Baltimore VA', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Health System', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Lauren Cooper, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}, {'name': 'Christopher deFilippi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inova Health Care Services'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inova Health Care Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'George Mason University', 'class': 'OTHER'}, {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}