NCT04702958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

January 5, 2021

Last Update Submit

October 6, 2023

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Differences in proteomic protein clusters between treatment groups

    How the biomarkers are different between groups

    baseline

  • Differences in trajectories of protein clusters between treatment groups

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

    90 days

Secondary Outcomes (2)

  • Differences in single biomarkers and biomarker trajectories between treatment groups

    baseline and 90 days

  • Differences in urinary protein levels between treatment groups

    baseline

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Participation in the TRANSFORM-HF trial or prescription of Torsemide or Furosemide
  • Willing to provide blood and urine sample at enrollment and follow-up

You may not qualify if:

  • Inability or unwillingness to comply with the study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Baltimore VA

Baltimore, Maryland, 21201, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Inova Health System

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk

Norfolk, Virginia, 23507, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Single biomarkers: high sensitive cardiac troponin T (hs-cTnT), amino terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor 15 (GDF-15), Cystatin C, high sensitive C-reactive protein (hsCRP), and interleukin 6 (IL6). * Urinary biomarkers: albumin, beta-2 microglobulin (B2M), cystatin C, epidermal growth factor (EGF), neutrophil gelatinase-associated lipocalin (NGAL/Lipocalin-2), osteopontin (OPN), uromodulin (UMOD) * Targeted discovery proteomics: Olink CARDIOVASCULAR III (CVD III) panel * Covid-19 antibodies

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Lauren Cooper, MD, MHS

    Northwell Health

    PRINCIPAL INVESTIGATOR

  • Christopher deFilippi, MD

    Inova Health Care Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 11, 2021

Study Start

December 10, 2020

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(9)