drugset / Trial / NCT07807384

Efficacy and Safety of an LVEF-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

NCT07807384 ↗

Phase 4 Not yet recruiting 115 enrolled Second Affiliated Hospital of Nanchang University
NaSingle-groupOpen-labelTreatment

Summary

This study aims to evaluate whether, under a treatment strategy primarily guided by left ventricular ejection fraction (LVEF), dose up-titration in adult patients with symptomatic obstructive hypertrophic cardiomyopathy who have received Mavacamten treatment for at least 12 weeks with a stable maintenance dose (as baseline) and with LVEF ≥55% can further reduce left ventricular outflow tract (LVOT) gradient after 24 weeks of treatment. It will also assess changes in hemodynamics, clinical symptoms, cardiac structure, and function. Furthermore, the study will conduct stratified analyses based on patients' baseline resting or Valsalva-provoked LVOT gradient levels at enrollment \[\<30 mmHg vs. ≥30 mmHg\] to explore differences in the aforementioned outcome measures among patients with different gradient levels, with the goal of providing evidence for individualized clinical dose adjustment.

Timeline

Start
2026-09
Primary completion
2026-09
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Mavacamten Small molecule 5 mg —
Subject Mavacamten Small molecule 10 mg —
Subject Mavacamten Small molecule 15 mg —