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SHR Neuro Cancer Cardio Lipid Metab Microb
Desai, MY; Nissen, SE; Abraham, T; Olivotto, I; Garcia-Pavia, P; Lopes, RD; Verheyen, N; Wever-Pinzon, O; Wolski, K; Jaber, W; Mitchell, L; Davey, D; Myers, J; Rano, T; Bhatia, V; Zhong, Y; Carter-Bonanza, S; Florea, V; Aronson, R; Owens, AT, , ODYSSEY-HCM, Investigators.
Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Design, Rationale, and Baseline Characteristics of ODYSSEY-HCM.
JACC Heart Fail. 2025; 13(2):358-370
Doi: 10.1016/j.jchf.2024.11.013
Web of Science
PubMed
FullText
FullText_MUG
- Co-authors Med Uni Graz
- Verheyen Nicolas Dominik
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- 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).
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Cardiomyopathy, Hypertrophic - drug therapy, physiopathology
- Female - administration & dosage
- Middle Aged - administration & dosage
- Male - administration & dosage
- Double-Blind Method - administration & dosage
- Exercise Test - administration & dosage
- Oxygen Consumption - physiology
- Adult - administration & dosage
- Aged - administration & dosage
- Uracil - analogs & derivatives, therapeutic use
- Benzylamines - therapeutic use
- Stroke Volume - physiology
- Treatment Outcome - administration & dosage
- Exercise Tolerance - physiology
- Find related publications in this database (Keywords)
- characteristics
- design
- mavacamten
- nonobstructive HCM