Trial Search Results

A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive HCM)

The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) treated in the real-world setting. The registry study also provide a real-world understanding of the current obstructive HCM patient population, treatment patterns, and clinical relevant outcomes for patients with symptomatic obstructive HCM in the US.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bristol-Myers Squibb

Stanford Investigator(s):

Eligibility


Inclusion Criteria:

   1. Willing and able to provide written informed consent form (ICF) and any required
   privacy authorization prior to the initiation of study procedures. i. Diagnosis of
   obstructive HCM consistent with 2020 American Heart Association/American College of
   Cardiology (AHA/ACC) guidelines. ii. Obstructive HCM is defined clinically by the
   presence of increased LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family
   history of HCM) in a nondilated ventricular chamber that is not solely explained by
   abnormal loading conditions (eg, another cardiac or systemic disease) and peak LVOT
   gradient of

   ≥ 30 mmHg at rest or with provocation.

   2. Has documented LVEF of ≥ 55% recorded by echocardiography within the last 6 months.

   3. Symptoms consistent with NYHA functional class II-IV.

   4. ≥ 18 years of age at the time of informed consent.

   5. Receiving BBs, non-dihydropyridine calcium. channel blockers (non-DHP CCBs),
   disopyramide, and/or mavacamten (once available) as part of routine clinical care; or
   currently receiving no treatment due to intolerance or failure of prior treatment (eg,
   BBs, non-DHP CCBs, or disopyramide) for obstructive HCM.

Exclusion Criteria:

   1. Known phenocopy disease (eg, Fabry disease, amyloidosis) or LV hypertrophy associated
   with hypertension.

   2. Documentation of any fixed obstruction of the outflow tract such as aortic valve
   stenosis or replacement.

   3. Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomy
   or percutaneous alcohol septal ablation [ASA]) within 6 months prior to enrollment;
   participants with an unsuccessful myectomy or percutaneous ASA performed > 6 months
   prior to enrollment may be enrolled.

   4. Naïve to treatment for obstructive HCM (ie, never treated with BBs, non-DHP CCBs, or
   disopyramide).

   5. Receiving an investigational therapeutic agent for obstructive HCM (eg,
   myosin-inhibitors other than mavacamten) in an interventional clinical trial at
   participant enrollment.

   6. Previously or currently enrolled in a long-term safety extension study of mavacamten
   (eg, EXPLORER-HCM [ClinicalTrials.gov, NCT03470545], MAVA-LTE [NCT03723655],
   PIONEER-OLE [NCT03496168], VALORHCM [NCT04349072], or MAVERICK [NCT03442764])

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting