Editorials
28 March 2024
Vol. 2 No. 1 (2024)
Clinical trial design, endpoints and regulatory considerations in heart failure
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All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
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Following the withdrawal of flosequinan in the early 1990s due to heightened mortality and fatal arrhythmia risks, regulatory agencies have demanded evidence of the efficacy of novel treatments in managing heart failure, with mortality and morbidity endpoints becoming more stringent criteria for approval. In recent times, regulatory agencies have exhibited a greater willingness to permit the evaluation of functional capacity as an efficacy endpoint, albeit limited to specific patient groupings. Consequently, a novel therapeutic intervention for heart failure may be granted approval provided that it enhances survival rates, decreases length of hospital stays, and/or safely improves functional capacity. This article reviews clinical trial design, trial endpoints and regulatory issues in heart failure trials.
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Citations
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Fishbein DP, Hellkamp AS, Mark DB, et al. Use of the 6-min walk distance to identify variations in treatment benefits from implantable cardioverterdefibrillator and amiodarone: results from the SCD-HeFT (Sudden Cardiac Death in Heart Failure trial). J Am Coll Cardiol 2014;63:2560-8. DOI: https://doi.org/10.1016/j.jacc.2014.02.602
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How to Cite
1.
Rosano GM. Clinical trial design, endpoints and regulatory considerations in heart failure. Global Cardiol [Internet]. 2024 Mar. 28 [cited 2025 Aug. 16];2(1). Available from: https://www.globalcardiology.info/site/article/view/18
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