TRANSFORM-HF Ancillary Mechanistic Study

Heart Failure Clinical Trial

Official title:

Mechanistic Insights From Longitudinal Changes in Blood and Urine Proteins to Explain Efficacy and Safety of Torsemide vs Furosemide After a Heart Failure Hospitalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04702958
• Other study ID #: R01HL154768-01
• Secondary ID: R01HL154768-01
• Status: Completed
• Start date: December 10, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: October 2023
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participation in the TRANSFORM-HF trial or prescription of Torsemide or Furosemide

• Willing to provide blood and urine sample at enrollment and follow-up

Exclusion Criteria:

• Inability or unwillingness to comply with the study requirements

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	Baltimore VA	Baltimore	Maryland
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	Northwell Health	Manhasset	New York
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Sentara Norfolk	Norfolk	Virginia

Sponsors (6)

Lead Sponsor	Collaborator
Inova Health Care Services	Duke University, George Mason University, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in proteomic protein clusters between treatment groups	How the biomarkers are different between groups	baseline
Primary	Differences in trajectories of protein clusters between treatment groups	How the protein clusters change over time from baseline to 90 days	90 days
Secondary	Differences in single biomarkers and biomarker trajectories between treatment groups	How the biomarkers are different between groups at baseline and how the biomarkers change over time from baseline to 90 days	baseline and 90 days
Secondary	Differences in urinary protein levels between treatment groups	How the in urinary protein levels are different between patient prescribed Torsemide vs Furosemide	baseline