Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World: United States Prospective Registry Study

Keywords

Obstructive Hypertrophic Cardiomyopathy, Obstructive HCM (oHCM), Mavacamten, Heart failure, oHCM, Cardiomyopathies, Hypertrophic Cardiomyopathy, Hypertrophy, Beta-blocker (BB) / non-dihydropyridine (non-DHP) calcium channel blocker (CCB) / disopyramide

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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])

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94117 United States
  • Stanford Health Care Hospital & Clinics accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information FDA Safety Alerts and Recalls BMS Clinical Trial Patient Recruiting
ID
NCT05489705
Study Type
Observational [Patient Registry]
Participants
Expecting 1500 study participants
Last Updated