Journal article
Pragmatic Design of Randomized Clinical Trials for Heart Failure: Rationale and Design of the TRANSFORM-HF Trial
JACC. Heart failure, Vol.9(5), pp.325-335
05/2021
DOI: 10.1016/j.jchf.2021.01.013
PMCID: PMC8087639
PMID: 33714745
Abstract
Randomized clinical trials are the foundation of evidence-based medicine and central to practice guidelines and patient care decisions. Nonetheless, randomized trials in heart failure (HF) populations have become increasingly difficult to conduct and are frequently associated with slow patient enrollment, highly selected populations, extensive data collection, and high costs. The traditional model for HF trials has become particularly difficult to execute in the United States, where challenges to site-based research have frequently led to modest U.S. representation in global trials. In this context, the TRANSFORM-HF (Torsemide Comparison with Furosemide for Management of Heart Failure) trial aims to overcome traditional trial challenges and compare the effects of torsemide versus furosemide among patients with HF in the United States. Loop diuretic agents are regularly used by most patients with HF and practice guidelines recommend optimal use of diuretic agents as key to a successful treatment strategy. Long-time clinical experience has contributed to dominant use of furosemide for loop diuretic therapy, although preclinical and small clinical studies suggest potential advantages of torsemide. However, due to the lack of appropriately powered clinical outcome studies, there is insufficient evidence to conclude that torsemide should be routinely recommended over furosemide. Given this gap in knowledge and the fundamental role of loop diuretic agents in HF care, the TRANSFORM-HF trial was designed as a prospective, randomized, event-driven, pragmatic, comparative-effectiveness study to definitively compare the effect of a treatment strategy of torsemide versus furosemide on long-term mortality, hospitalization, and patient-reported outcomes among patients with HF. (TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure [TRANSFORM-HF]; NCT03296813).
Details
- Title: Subtitle
- Pragmatic Design of Randomized Clinical Trials for Heart Failure: Rationale and Design of the TRANSFORM-HF Trial
- Creators
- Stephen J GreeneEric J Velazquez - Yale UniversityKevin J Anstrom - Duke Clinical Research Institute, Durham, North Carolina, USAEric L Eisenstein - Duke Clinical Research Institute, Durham, North Carolina, USAShelly Sapp - Duke Clinical Research Institute, Durham, North Carolina, USAShelby Morgan - Duke Clinical Research Institute, Durham, North Carolina, USATina Harding - Duke Clinical Research Institute, Durham, North Carolina, USAVandana Sachdev - National Heart Lung and Blood InstituteFassil Ketema - National Heart Lung and Blood InstituteDong-Yun Kim - National Heart Lung and Blood InstitutePatrice Desvigne-Nickens - National Heart Lung and Blood InstituteBertram Pitt - University of MichiganRobert J MentzToRsemide compArisoN With furoSemide FORManagement of Heart Failure (TRANSFORM-HF) Investigators
- Contributors
- Ernesto Ruiz Duque (Contributor) - University of Iowa, Cardiovascular Medicine
- Resource Type
- Journal article
- Publication Details
- JACC. Heart failure, Vol.9(5), pp.325-335
- DOI
- 10.1016/j.jchf.2021.01.013
- PMID
- 33714745
- PMCID
- PMC8087639
- NLM abbreviation
- JACC Heart Fail
- ISSN
- 2213-1779
- eISSN
- 2213-1787
- Grant note
- U01 HL125478 / NHLBI NIH HHS U01 HL125511 / NHLBI NIH HHS
- Language
- English
- Date published
- 05/2021
- Academic Unit
- Cardiovascular Medicine; Internal Medicine
- Record Identifier
- 9984359668602771
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