TRANSFORM-HF Ancillary Mechanistic Study
- Conditions
- Heart Failure
- Registration Number
- NCT04702958
- Lead Sponsor
- Inova Health Care Services
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Participation in the TRANSFORM-HF trial or prescription of Torsemide or Furosemide
- Willing to provide blood and urine sample at enrollment and follow-up
- Inability or unwillingness to comply with the study requirements
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in proteomic protein clusters between treatment groups baseline How the biomarkers are different between groups
Differences in trajectories of protein clusters between treatment groups 90 days How the protein clusters change over time from baseline to 90 days
- Secondary Outcome Measures
Name Time Method Differences in single biomarkers and biomarker trajectories between treatment groups baseline and 90 days How the biomarkers are different between groups at baseline and how the biomarkers change over time from baseline to 90 days
Differences in urinary protein levels between treatment groups baseline How the in urinary protein levels are different between patient prescribed Torsemide vs Furosemide
Trial Locations
- Locations (9)
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Baltimore VA
🇺🇸Baltimore, Maryland, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Northwell Health
🇺🇸Manhasset, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Inova Health System
🇺🇸Falls Church, Virginia, United States
Sentara Norfolk
🇺🇸Norfolk, Virginia, United States
Yale University School of Medicine🇺🇸New Haven, Connecticut, United States