drugset / Trial / NCT05582395
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
Timeline
- Start
- 2022-12-14
- Primary completion
- 2025-03-06
- Completion
- 2025-10-20
Publications
- Desai MY, Owens AT, Abraham T, Olivotto I, Garcia-Pavia P, Lopes RD, Elliott P, Fernandes F, Verheyen N, Maier L, Meder B, Azevedo O, Kitaoka H, Wolski K, Wang Q, Jaber W, Mitchell L, Myers J, Rano T, Gong Z, Zhong Y, Carter-Bonanza S, Florea V, Aronson R, Nissen SE; ODYSSEY-HCM Investigators. Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy. N Engl J Med. 2025 Sep 11;393(10):961-972. doi: 10.1056/NEJMoa2505927. Epub 2025 Aug 30.
- Desai MY, Olivotto I, Abraham T, Nissen SE, Garcia-Pavia P, Lopes RD, Elliott PM, Fernandes F, de Barros Correia E, Barriales-Villa R, Zorio E, Arad M, Shin SH, Verheyen N, Meder B, Azevedo O, Kitaoka H, Wolski K, Wang Q, Suryawanshi B, Wang Z, Florea V, Aronson R, Owens AT; ODYSSEY-HCM Investigators. Effects of Mavacamten on Cardiac Biomarkers in Nonobstructive Hypertrophic Cardiomyopathy: Insights From the ODYSSEY-HCM Trial. J Am Coll Cardiol. 2025 Dec 16;86(24):2418-2433. doi: 10.1016/j.jacc.2025.08.017. Epub 2025 Aug 27.
- Sikand N, Stendahl J, Sen S, Lampert R, Day S. Current management of hypertrophic cardiomyopathy. BMJ. 2025 May 27;389:e077274. doi: 10.1136/bmj-2023-077274.
- 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 Feb;13(2):358-370. doi: 10.1016/j.jchf.2024.11.013.
- O'Malley PA. Mavacamten (CAMZYOS) First-in-Class Small-Molecule Myosin Inhibitor for Treatment of Obstructive Hypertrophic Cardiomyopathy. Clin Nurse Spec. 2024 May-Jun 01;38(3):119-121. doi: 10.1097/NUR.0000000000000821. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mavacamten | Small molecule | — | — |
Indications
No indication recorded.