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Gradual Tapering or Discontinuation of Beta-Blockers After Stabilization With Mavacamten Therapy
Sponsor: First Affiliated Hospital of Wenzhou Medical University
Summary
This multicenter, randomized, open-label, parallel-group, non-inferiority trial will evaluate whether sequential tapering and discontinuation of beta-blockers is non-inferior to maintenance of the baseline stable beta-blocker dose in adult patients with obstructive hypertrophic cardiomyopathy (oHCM) who have achieved predefined clinical and hemodynamic stability during mavacamten treatment. Eligible participants will be randomly assigned in a 1:1 ratio to a sequential tapering and discontinuation group or a baseline stable-dose maintenance group. In the tapering group, the beta-blocker dose will be reduced stepwise approximately every 4 weeks, with complete discontinuation planned at Week 12 if predefined safety and stability criteria are met. Participants will be followed through Week 24. The primary objective is to compare the proportion of participants who maintain clinical and hemodynamic stability without protocol-defined treatment failure through Week 24. The feasibility and safety of complete beta-blocker discontinuation will also be evaluated.
Official title: Feasibility and Safety of Sequential Tapering and Discontinuation of Beta-blockers in Patients With Obstructive Hypertrophic Cardiomyopathy After Achieving Hemodynamic Targets With Mavacamten: a Multicenter, Randomized, Open-label, Parallel-group, Non-inferiority Trial (STEP-oHCM)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
286
Start Date
2026-12
Completion Date
2028-12
Last Updated
2026-09-11
Healthy Volunteers
No
Interventions
Beta-Blocker Sequential Tapering and Discontinuation
Participants will undergo sequential tapering of their baseline beta-blocker therapy. The daily beta-blocker dose will be reduced approximately every 4 weeks following a planned dose pathway of approximately 100%, 75%, 50%, 25%, and 0% of the randomization baseline daily dose. Complete discontinuation is planned at Week 12 if predefined clinical, hemodynamic, and safety criteria are met. Dose reduction may be paused or delayed, and dose rollback or rescue treatment may be implemented according to protocol-defined criteria.
Beta-Blocker Baseline Stable-Dose Maintenance
Participants will continue the beta-blocker type, dosing frequency, and daily dose that were stable at randomization throughout the 24-week randomized follow-up period, unless dose modification is clinically required because of efficacy or safety concerns according to the study protocol.
Locations (1)
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China