NCT06947590Active, not recruiting
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
This study aimed to evaluate the efficacy and safety of Mavacamten compared to no treatment in patients with symptomatic latent obstructive hypertrophic cardiomyopathy. The trial was randomized into two groups: Mavacamten group and Non-Mavacamten group. Over the 30-week treatment period, patients underwent a series of assessments at predefined time points, including transthoracic echocardiography, electrocardiogram (ECG), Holter monitoring, NYHA functional classification, Kansas City Cardiomyopathy Questionnaire (KCCQ), and cardiac biomarkers.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 20 Apr 2025
- Start date
- 20 Apr 2025
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Xu Liu
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT06947590
What you commit to
- Study type: Interventional
- Planned participants: 78
- From 20 Apr 2025 to the primary completion date, 1 Feb 2026
- 1 site in 1 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
- Currently using or having used prohibited medications within 14 days prior to screening, such as cytochrome CYP2C19 inhibitors (e.g., omeprazole or esomeprazole) or strong CYP3A4 inhibitors.
- Patients currently receiving or planning to receive treatment with disopyramide, cibenzoline, ranolazine, or a combination of beta-blockers with verapamil or diltiazem.
Other illness
- Any acute or severe comorbidities (e.g., severe infections or hematological, renal, metabolic, gastrointestinal, or endocrine dysfunction).
- History of syncope or sustained ventricular tachyarrhythmia during exercise within the past 6 months.
Other
- Life expectancy of less than 1 year.
- Pregnant or breastfeeding women.
- Atrial fibrillation (AF).
Who the study is looking for
- Age ≥18 years.
- Weight greater than 45 kg.
- Adequate acoustic windows to allow for accurate transthoracic echocardiograms (TTEs).
- Diagnosis of latent obstructive hypertrophic cardiomyopathy, in accordance with the current guidelines of the American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Chinese Society of Cardiology.
- Left ventricular ejection fraction (LVEF) ≥55% at rest, confirmed by the echocardiography core laboratory.
- New York Heart Association (NYHA) Class II or III symptoms at the time of screening.
- Resting oxygen saturation ≥90% at the time of screening.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.