Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Design, Rationale, and Baseline Characteristics of ODYSSEY-HCM
- PMID: 39909647
- DOI: 10.1016/j.jchf.2024.11.013
Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Design, Rationale, and Baseline Characteristics of ODYSSEY-HCM
Abstract
There are no approved therapies for patients with symptomatic nonobstructive hypertrophic cardiomyopathy (nHCM). The authors describe the baseline characteristics of ODYSSEY-HCM (A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy), a phase 3, randomized, double-blind, placebo-controlled trial conducted worldwide at 201 sites evaluating mavacamten in symptomatic adult patients with nHCM. The 2 primary endpoints are the changes from baseline to week 48 in: 1) Kansas City Cardiomyopathy Questionnaire 23-item Clinical Summary Score; and 2) peak oxygen consumption (pVO2) on cardiopulmonary exercise testing. Dose titrations are made on blinded core laboratory assessments. Of 1,088 patients screened, 580 are randomized (mean age 56 ± 15 years, 46% women, 43% with family histories). All patients are nonobstructive and symptomatic (70% in NYHA functional class II and 30% class III), with a mean Kansas City Cardiomyopathy Questionnaire 23-item Clinical Summary Score of 58 ± 20, and 77% are on beta-blockers. The mean left ventricular ejection fraction and pVO2 are 66% ± 4% and 18 ± 6 mL/kg/min, respectively. ODYSSEY-HCM will report if mavacamten improves patient-reported health status and exercise capacity in patients with symptomatic nHCM. (A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy (ODYSSEY-HCM); NCT05582395).
Keywords: characteristics; design; mavacamten; nonobstructive HCM.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures The ODYSSEY-HCM study was funded by Bristol Myers Squibb. Bristol Myers Squibb’s policy on data sharing may be found at https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html. Dr Desai is a consultant for and has research agreements with Bristol Myers Squibb, Edgewise, Tenaya, Viz AI, and Cytokinetics. Dr Olivotto has received personal fees from Bristol Myers Squibb, Amicus, Sanofi Genzyme; has received consulting and advisory fees from Bristol Myers Squibb, Cytokinetics, Sanofi Genzyme, Amicus, Bayer, Tenaya, Rocket Pharma, Edgewise, and Lexeo; and has received research grants from Bristol Myers Squibb, Cytokinetics, Sanofi Genzyme, Amicus, Bayer, Menarini International, Chiesi, and Boston Scientific. Dr Lopes has received grants from or has contracts with Amgen, Medtronic, Bristol Myers Squibb, Pfizer, GlaxoSmithKline, and Sanofi; has received consulting fees from AstraZeneca, Novo Nordisk, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, and Pfizer; and has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AstraZeneca, Daiichi-Sankyo, Novo Nordisk, and Pfizer. Dr Garcia-Pavia has received consulting fees from BioMarin, Bristol Myers Squibb, Cytokinetics, Edgewise, Lexeo, and Rocket Pharmaceuticals; and has received speaker fees, advisory board fees, and unrestricted research grants from Bristol Myers Squibb. Dr Verheyen has received speaker fees, advisory board fees, and unrestricted research grants from Bristol Myers Squibb. Dr Owens is a consultant for Alexion, Bayer, Bristol Myers Squibb, Cytokinetics, Edgewise, Lexeo, BioMarin, Tenaya, Stealth, and CorVista. Ms Wolski, Ms Davey, and Ms Mitchell are employees of C5Research and the Cleveland Clinic. Dr Aronson, Dr Florea, Ms Bonanza Carter, Dr Rano, Dr Zhong, and Dr Bhatia are employees of Bristol Myers Squibb. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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