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Completed

NCT Number: NCT04702958

TRANSFORM-HF Ancillary Mechanistic Study

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University School of Medicine, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Differences in proteomic protein clusters between treatment groups

    Time frame: baseline

    How the biomarkers are different between groups

  2. Differences in trajectories of protein clusters between treatment groups

    Time frame: 90 days

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

Secondary outcomes

  1. Differences in single biomarkers and biomarker trajectories between treatment groups

    Time frame: 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

  2. Differences in urinary protein levels between treatment groups

    Time frame: baseline

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

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Collaborators

  • Duke University
  • George Mason University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)
  • University of Maryland, Baltimore

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2021
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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