NCT07807384Not yet recruitingPhase 4
Efficacy and Safety of an LVEF-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Efficacy and Safety of a Left Ventricular Ejection Fraction-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Open-Label Study
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- First submitted
- 25 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07807384
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 115
- From 1 Sept 2026 to the primary completion date, 30 Sept 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Hypertrophy caused by other systemic diseases with a clear etiology. 2. Planned use of strong CYP2C19 inhibitors, moderate to strong CYP2C19 inducers, or CYP3A4 inducers during the study. 3. Planned use of disopyramide, ranolazine, verapamil combined with beta-blockers, or diltiazem combined with beta-blockers during the study. 4. Previous intolerance to Mavacamten. 5. Severe hepatic or renal dysfunction. 6. Pregnant or lactating women.
Who the study is looking for
- 1\. Adult patients diagnosed with obstructive hypertrophic cardiomyopathy (HCM) and classified as New York Heart Association (NYHA) functional class II-III. 2. Have received stable Mavacamten treatment for at least 12 weeks with a stable dose. 3. LVEF ≥ 55%.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.