Clinical trial NCT04702958: TRANSFORM-HF Ancillary Mechanistic Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Duke University
name: George Mason University
name: University of Maryland, Baltimore
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-01-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in proteomic protein clusters between treatment groups
timeFrame: baseline
measure: Differences in trajectories of protein clusters between treatment groups
timeFrame: 90 days
Secondary outcomes:
measure: Differences in single biomarkers and biomarker trajectories between treatment groups
timeFrame: baseline and 90 days
measure: Differences in urinary protein levels between treatment groups
timeFrame: baseline
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore VA
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Falls Church
country: United States
facility: Inova Health System
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk
state: Virginia
Study officials:
affiliation: Northwell Health
name: Lauren Cooper, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Inova Health Care Services
name: Christopher deFilippi, MD
role: PRINCIPAL_INVESTIGATOR
References: