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TRANSFORM-HF Ancillary Mechanistic Study

Sponsor
Inova Health Care Services (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04702958
Collaborator
National Institutes of Health (NIH) (NIH), Duke University (Other), George Mason University (Other), University of Maryland, Baltimore (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
250
Enrollment
8
Locations
35.7
Anticipated Duration (Months)
31.3
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Dec 10, 2020
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Differences in proteomic protein clusters between treatment groups [baseline]

      How the biomarkers are different between groups

    2. Differences in trajectories of protein clusters between treatment groups [90 days]

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

    Secondary Outcome Measures

    1. 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

    2. Differences in urinary protein levels between treatment groups [baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale University School of Medicine New Haven Connecticut United States 06510
    2 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    3 Baltimore VA Baltimore Maryland United States 21201
    4 University of Minnesota Minneapolis Minnesota United States 55455
    5 Northwell Health Manhasset New York United States 11030
    6 Duke University Hospital Durham North Carolina United States 27710
    7 Inova Health System Falls Church Virginia United States 22042
    8 Sentara Norfolk Norfolk Virginia United States 23507

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Lauren Cooper, MD, MHS, Inova Health Care Services
    • Principal Investigator: Christopher deFilippi, MD, Inova Health Care Services

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Inova Health Care Services
    ClinicalTrials.gov Identifier:
    NCT04702958
    Other Study ID Numbers:
    • R01HL154768-01
    • R01HL154768-01
    First Posted:
    Jan 11, 2021
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jun 1, 2022