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CompletedNCT04702958Updated Oct 10, 2023

TRANSFORM-HF Ancillary Mechanistic Study

An observational study in Heart Failure, sponsored by Inova Health Care Services. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Inova Health Care Services · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Heart Failure

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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 150 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Inova Health Care Services is the lead sponsor of 84 studies on the registry; 20 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Inability or unwillingness to comply with the study requirements
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Torsemide

    Patients enrolled in the TRANSFORM-HF study randomized to Torsemide, or patients prescribed Torsemide at hospital discharge

  • Furosemide

    Patients enrolled in the TRANSFORM-HF study randomized to Furosemide, or patients prescribed Furosemide at hospital discharge

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What researchers measure

Primary outcomes

  1. Differences in proteomic protein clusters between treatment groups

    How the biomarkers are different between groups

    Time frame: baseline

  2. Differences in trajectories of protein clusters between treatment groups

    How the protein clusters change over time from baseline to 90 days

    Time frame: 90 days

Secondary outcomes

  1. 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

    Time frame: baseline and 90 days

  2. Differences in urinary protein levels between treatment groups

    How the in urinary protein levels are different between patient prescribed Torsemide vs Furosemide

    Time frame: baseline

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Study locations

9 sites
  • Yale University School of Medicine
    New Haven, Connecticut 06510, United States
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70121, United States
  • Baltimore VA
    Baltimore, Maryland 21201, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Northwell Health
    Manhasset, New York 11030, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • Duke University Hospital
    Durham, North Carolina 27710, United States
  • Inova Health System
    Falls Church, Virginia 22042, United States
  • Sentara Norfolk
    Norfolk, Virginia 23507, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04702958
Lead sponsor
Inova Health Care Services
Collaborators
National Institutes of Health (NIH), Duke University, George Mason University, University of Maryland, Baltimore, National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Jan 11, 2021
Start date
Dec 10, 2020
Primary completion
May 30, 2023
Completion
May 30, 2023
Last update
Oct 10, 2023

Study contacts

Lauren Cooper, MD, MHS
principal investigator · Northwell Health
Christopher deFilippi, MD
principal investigator · Inova Health Care Services

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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