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. 2025 Feb;13(2):346-357.
doi: 10.1016/j.jchf.2024.11.011.

Aficamten vs Metoprolol for Obstructive Hypertrophic Cardiomyopathy: MAPLE-HCM Rationale, Study Design, and Baseline Characteristics

Pablo Garcia-Pavia  1 , Ozlem Bilen  2 , Melissa Burroughs  3 , Juan Pablo Costabel  4 , Edileide de Barros Correia  5 , Anne M Dybro  6 , Perry Elliott  7 , Neal K Lakdawala  8 , Amy Mann  9 , Ajith Nair  10 , Michael E Nassif  11 , Steen H Poulsen  6 , Patricia Reant  12 , P Christian Schulze  13 , Andrew Wang  14 , Indrias Berhane  15 , Stephen B Heitner  15 , Daniel L Jacoby  15 , Stuart Kupfer  15 , Fady I Malik  15 , Lisa Meng  15 , Regina Sohn  15 , Amy Wohltman  15 , Michael A Fifer  16 ; MAPLE-HCM Study Investigators
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Free article

Aficamten vs Metoprolol for Obstructive Hypertrophic Cardiomyopathy: MAPLE-HCM Rationale, Study Design, and Baseline Characteristics

Pablo Garcia-Pavia et al. JACC Heart Fail. 2025 Feb.
Free article

Abstract

Beta-blockers and nondihydropyridine calcium-channel blockers have been standard-of-care (SOC) medications for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), even though these agents do not directly affect the underlying pathophysiology of the disease. Cardiac myosin inhibitors act by decreasing the number of myosin heads binding to actin, reducing the pathologic hypercontractility of HCM, and have been shown to improve exercise capacity and alleviate symptoms in oHCM when added to SOC medications. Cardiac myosin inhibitors are currently considered as second-line therapy in the absence of head-to-head comparison studies vs SOC medications. The aim of the ongoing phase 3 study MAPLE-HCM (Metoprolol vs Aficamten in Patients With LVOT Obstruction on Exercise Capacity in HCM) is to fill this evidence gap by evaluating aficamten as both first-line therapy for newly diagnosed oHCM and as a monotherapy alternative for patients currently on SOC drugs. The authors describe the rationale, design, and baseline characteristics of patients in this study. (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM [MAPLE-HCM]; NCT05767346).

Keywords: aficamten; beta-blocker; gradient; hypertrophic cardiomyopathy; obstructive.

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Conflict of interest statement

Funding Support and Author Disclosures The MAPLE-HCM and FOREST-HCM trials are funded by Cytokinetics. Representatives of Cytokinetics have been involved in the design and conduct of the study reported in this paper. Dr Garcia-Pavia has received Speakers Bureau fees from Alnylam Pharmaceuticals, AstraZeneca, Bristol Myers Squibb, BridgeBio, Intellia, Ionis Pharmaceuticals, Novo Nordisk, and Pfizer; has received consulting fees from Alexion, Alnylam Pharmaceuticals, AstraZeneca, Attralus, Bayer, BioMarin, Bristol Myers Squibb, BridgeBio, Cytokinetics, Daiichi-Sankyo, Edgewise, General Electric, Intellia, Idoven, Ionis Pharmaceuticals, Lexeo, Pfizer, Neuroimmune, Novo Nordisk, and Rocket Pharmaceuticals; and has received research and educational support to the institution from Alnylam, AstraZeneca, BridgeBio, Intellia, Novo Nordisk, and Pfizer. Dr Bilen has received consulting fees from Bristol Myers Squibb and Cytokinetics. Dr Burroughs has received consulting fees from Bristol Myers Squibb, Cytokinetics, and Novartis. Dr Costabel has received Speakers Bureau fees from Bristol Myers Squibb and Pfizer; and has received consulting fees from Bristol Myers Squibb, Cytokinetics, and Pfizer. Dr Dybro has received speaker fees from Pfizer and Bristol Myers Squibb. Dr Elliott has received consulting fees from Bristol Myers Squibb, Pfizer, and Cytokinetics; has received speaker fees from Pfizer; and has received an unrestricted grant from Sarepta. Dr Lakdawala has received consulting fees from Pfizer, Bristol Myers Squibb, Cytokinetics, Tenaya, Akros, Neuvocor, and Alexion; and has received unrestricted research support from Pfizer and Bristol Myers Squibb. Ms Mann has received consulting fees from Bristol Myers Squibb and Cytokinetics. Dr Nassif has received research and grant support from AstraZeneca and Cytokinetics; and has received consulting and advisory fees from Vifor and Cytokinetics. Dr Poulsen has received consulting fees from Pfizer and BridgeBio. Dr Reant has received consulting fees from Cytokinetics, Bristol Myers Squibb, Pfizer, Alnylam, Amicus Therapeutics, and Sanofi. Dr Schulze has received honoraria and travel support from Bayer, AstraZeneca, Daiichi-Sankyo, Novartis, Actelion, Roche, Sanofi, Pharmacosmos, Medtronic, Thoratec, Boehringer Ingelheim, HeartWare, Coronus, Abbott, Edwards LifeSciences, Boston Scientific, St. Jude Medical, Abiomed, and the German Cardiac Society; has received research support from the National Institutes of Health, the German Research Foundation, the Else Kröner Fresenius Foundation, the German Heart Foundation, the European Society of Cardiology, Actelion, Medtronic, the Federal Ministry of Education and Research of Germany, Abiomed, Boehringer Ingelheim, and Boston Scientific; and has served on advisory boards for the German Research Council, Cytokinetics, Eurotransplant, Novartis, Bayer, Pharmacosmos, AstraZeneca, Boehringer Ingelheim, the German Cardiac Society, and the European Society of Cardiology. Drs Berhane, Heitner, Jacoby, Kupfer, Malik, Meng, Sohn, and Wohltman are employees of Cytokinetics and hold stock in Cytokinetics. Dr Fifer has received consulting fees from Bristol Myers Squibb, Cytokinetics, Edgewise Therapeutics, and Viz.ai; and has received research grants from Bristol Myers Squibb and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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