A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US

N/AActive Not RecruitingNCT07107373

Bristol-Myers Squibb150 enrolled

Overview

The purpose of this study is to evaluate the real-world safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers in the US

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Interventions

MavacamtenDRUG

According to the product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years at the index date * Prescription of mavacamten for the treatment of Obstructive hypertrophic cardiomyopathy (oHCM) with NYHA Class II or III * ≥ 12 weeks of follow-up after prescription of mavacamten, except for the baseline data reporting Exclusion Criteria: * Data collection as part of a clinical trial during the study period * Participation in a myosin inhibitor clinical trial

Locations (1)

University of California, San Francisco (UCSF)

San Francisco, California, United States

Outcomes

Primary Outcomes

New York Heart Association (NYHA) functional class

Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index

Left ventricular outflow tract (LVOT) gradient and associated parameters

Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index

Left ventricular ejection fraction (LVEF) and associated parameters

Time frame: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index

Secondary Outcomes

Mavacamten dose at initiation

Time frame: Day 1

Mavacamten dose change

Time frame: Up to 72 weeks

Reason for mavacamten dose change

Time frame: Up to 72 weeks

Reason for mavacamten permanent discontinuation

Time frame: Up to 72 weeks

Reason for treatment interruption

Time frame: Up to 72 weeks

Prior Obstructive hypertrophic cardiomyopathy (oHCM) therapies

Time frame: Baseline

Concurrent Obstructive hypertrophic cardiomyopathy (oHCM) therapies

Time frame: Up to 72 weeks

Other cardiovascular-related treatments prescribed

Data from ClinicalTrials.gov

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