TRANSFORM-HF Ancillary Mechanistic Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04702958

Enrollment

150

Registered

2021-01-11

Start date

2020-12-10

Completion date

2023-05-30

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results