# TRANSFORM-HF DCC

> **NIH NIH U01** · DUKE UNIVERSITY · 2021 · $622,534

## Abstract

Heart Failure (HF) is the most frequent cause of hospitalization among patients aged 65 or greater and leads
to an enormous personal, societal and economic burden for the US population. Loop diuretics such as
torsemide and furosemide are a cornerstone of HF therapy utilized to improve congestive symptoms. Prior
data suggest that torsemide compared to furosemide advantageously alters pathophysiological mechanisms
associated with progression, has a favorable pharmacodynamic profile and may decrease HF morbidity and
mortality. Yet, furosemide is overwhelmingly utilized in daily practice which highlights clinical equipoise and an
unmet need for an adequately powered study to definitively determine whether torsemide compared to
furosemide improves outcomes to guide clinical practice. The ToRsemide compArisoN with furoSemide
FOR Management of HF (TRANSFORM-HF) trial is a robustly-powered, prospective, randomized,
comparative-effectiveness study which will change guidelines and have immediate clinical
implications for the management of millions of patients with HF. The primary hypothesis of the
TRANSFORM-HF trial is that torsemide will reduce all-cause mortality by a relative 15% compared with
furosemide over a period of 12 months. Important secondary hypotheses include that torsemide compared to
furosemide will 1) reduce 1-year all-cause mortality and first HF re-hospitalization; 2) improve health-related
quality of life; and 3) increase survival time and decrease total cardiovascular hospitalizations compared with
furosemide. The specific aims of the TRANSFORM-HF Clinical Coordinating Center (CCC) and Data
Coordinating Center (DCC) are to (1) Develop and administrate a clinical trial organization to efficiently
coordinate study conduct and analysis; (2) Implement and monitor a “real-world”, large-scale, pragmatic,
clinical-effectiveness study using streamlined data acquisition with call center follow-up, and (3) Disseminate
the trial results and implications to a broad audience and serve as a prototype for future pragmatic clinical
trials. Our prospective, unblinded, 2-arm, phase III clinical trial of 6,000 hospitalized HF patients targeting
robust enrollment of racial and ethnic minorities and women will randomize subjects 1:1 to either oral
torsemide or furosemide prior to discharge. Enrollment will occur at 50 US hospital sites with established HF
clinical excellence. A systematic data acquisition approach will minimize investigator and subject burden and
use a call center at 6 and 12 months to document vital status, medication adherence, and health-related quality
of life, and to acquire hospitalization information. The TRANSFORM-HF trial will be led by investigators and an
operations team with substantial experience and expertise in HF care, clinical trials, data integration and
administration working within the highly proven environment of the Duke Clinical Research Institute. This
application is submitted as two clustered R01 grant proposals wh...

## Key facts

- **NIH application ID:** 10232105
- **Project number:** 5U01HL125478-05
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Hrishikesh Chakraborty
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $622,534
- **Award type:** 5
- **Project period:** 2017-08-15 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10232105

## Citation

> US National Institutes of Health, RePORTER application 10232105, TRANSFORM-HF DCC (5U01HL125478-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10232105. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*