NCT05489705

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)

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,600 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obstructive Hypertrophic Cardiomyopathy

Interventions

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

Timeline

• Start date: 2022-08-16
• Primary completion: 2029-08-17
• Completion: 2029-08-17
• First posted: 2022-08-05
• Last updated: 2025-11-06

Locations

99 sites across 7 countries: United States, Austria, France, Germany, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study