Pragmatic Design of Randomized Clinical Trials for Heart Failure: Rationale and Design of the TRANSFORM-HF Trial

Autor: Greene, Stephen J., Velazquez, Eric J., Anstrom, Kevin J., Eisenstein, Eric L., Sapp, Shelly, Morgan, Shelby, Harding, Tina, Sachdev, Vandana, Ketema, Fassil, Kim, Dong-Yun, Desvigne-Nickens, Patrice, Pitt, Bertram, Mentz, Robert J.
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: JACC Heart Fail
Popis: 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 (US), where challenges to site-based research have frequently led to modest US 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 US. Loop diuretics are regularly used by the majority of patients with HF and practice guidelines recommend optimal use of diuretics as key to a successful treatment strategy. Long-time clinical experience has contributed to dominant use of furosemide for loop diuretic therapy, although pre-clinical 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 diuretics 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.
Databáze: OpenAIRE