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)

Conditions

• Obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mavacamten — DRUG
  As per product label
• Non-mavacamten symptomatic oHCM therapy — DRUG
  Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label

Study Details

This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment. United States Sub-Study: The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Europe Sub-Study: The purpose of this study is to evaluate the effectiveness and safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting.

Key Dates

Start date

Aug 16, 2022

Status verified

Nov 2025

Primary completion

Aug 17, 2029

Completion

Aug 17, 2029

Study Design

Enrollment

1,600 participants (estimated)

Arms

• Arm: Mavacamten
  Participants will receive mavacamten as prescribed by a physician according to standard of care for symptomatic oHCM
• Arm: Beta-blocker (BB) / non-dihydropyridine (non-DHP) calcium channel blocker (CCB) / disopyramide
  Participants will receive BB/non-DHP CCB/disopyramide as prescribed by a physician according to standard of care for symptomatic oHCM

Primary Outcome Measure

Incidence rate of new or worsening heart failure due to systolic dysfunction among participants with symptomatic obstructive HCM during periods of exposure to mavacamten and other oHCM treatment [ Time Frame: Up to 5 Years ]

Central Contacts

• BMS Study Connect Contact Center www.BMSStudyConnect.com
  855-907-3286
  [email protected]
• First line of the email MUST contain the NCT# and Site #.

Locations (62)

Find similar trials in Anchorage, AK

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