Effect of mavacamten on heart blood flow in obstructive hypertrophic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the impact of mavacamten treatment on blood flow in the heart muscle of patients diagnosed with obstructive hypertrophic cardiomyopathy (oHCM). Participants will receive mavacamten as prescribed by their physician and will undergo two myocardial PET-CT scans: one before starting treatment and another after 12 months of therapy. The study seeks to determine if mavacamten improves myocardial blood flow, providing insights into its effectiveness for this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willingness and ability to provide written informed consent
2. Willingness and ability to comply with scheduled visits and study procedures
3. Male or female, aged 18-85 years
4. Diagnosed with obstructive hypertrophic cardiomyopathy according to presence of a left ventricular wall thickness of ≥15 mm that is otherwise unexplained by abnormal loading conditions (e.g., hypertension, valvular, congenital disease) or infiltrative cardiomyopathies. Unexplained left ventricular wall thickness of ≥13 mm is sufficient for diagnosis in relatives of individuals with hypertrophic cardiomyopathy or those who are genotype positive.
5. Has been prescribed mavacamten consistent with US Prescribing Information
6. Ability and intention to adhere to oral mavacamten therapy as prescribed by treating physician for the duration of study participation
7. For females of reproductive potential: negative pregnancy test at screening/baseline and 12 month visits.

Exclusion Criteria:

1. Pregnancy or lactation
2. Known hypersensitivity to components of mavacamten or regadenoson
3. Prior treatment with mavacamten or aficamten

11\. Over weight limit for imaging gantry. 12. To minimize the risk of participants undergoing PET/CT with inadequate image quality, participants with left ventricular systolic dysfunction or lung disease will be excluded.

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Assessing health changes in patients with obstructive hypertrophic cardiomyopathy treated with mavacamten

  This study is testing how well the medication mavacamten helps adults with obstructive hypertrophic cardiomyopathy feel and do better in their everyday lives.

  Recruiting Bristol-Myers Squibb · Boston, Massachusetts · NCT06551129

• Assessing the safety of mavacamten in Korean patients with obstructive hypertrophic cardiomyopathy

  This study is testing how safe the medication mavacamten is for adults in Korea who have symptoms of obstructive hypertrophic cardiomyopathy.

  Recruiting Bristol-Myers Squibb · Seoul and 1 other locations · NCT06146660

• Registry to assess patient characteristics and outcomes in obstructive hypertrophic cardiomyopathy

  This study is trying to learn more about how people with obstructive hypertrophic cardiomyopathy are treated and what their experiences are, especially for those using the medication mavacamten.

  Recruiting at 76 sites Bristol-Myers Squibb · Anchorage, Alaska and 100 other locations · NCT05489705

• Mavacamten outcomes and real-world patient and physician experiences for obstructive HCM in the US

  See how mavacamten works and what patients and doctors experience for adults with obstructive hypertrophic cardiomyopathy treated in US community practice.

  Recruiting Bristol-Myers Squibb · Bollington, Macclesfield · NCT07557498

• Mavacamten treatment for obstructive hypertrophic cardiomyopathy in Japan

  This project will try mavacamten in patients in Japan with obstructive hypertrophic cardiomyopathy to see if it works well and is safe during routine care.

  Recruiting Bristol-Myers Squibb · Tokyo · NCT07383025

• Ademetionine treatment for obstructive hypertrophic cardiomyopathy

  This study will test whether taking ademetionine can improve exercise capacity, symptoms, heart structure and quality of life in adults with obstructive hypertrophic cardiomyopathy.

  Recruiting at 2 sites Phase 2 China National Center for Cardiovascular Diseases · Beijing and 2 other locations · NCT07367724

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.