TRANSFORM-HF Ancillary Mechanistic Study

NCT ID: NCT04702958

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-10

Study Completion Date

2023-05-30

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Torsemide

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

No interventions assigned to this group

Furosemide

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

George Mason University

OTHER

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Inova Health Care Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren Cooper, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Christopher deFilippi, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Health Care Services

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Baltimore VA

Baltimore, Maryland, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Northwell Health

Manhasset, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Duke University Hospital

Durham, North Carolina, United States

Site Status

Inova Health System

Falls Church, Virginia, United States

Site Status

Sentara Norfolk

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL154768-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL154768-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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