Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US

Bristol-Myers Squibb362 enrolled

Overview

The purpose of this study is to understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy (HCM) treated with mavacamten, and to understand patient and physician experiences with mavacamten treatment, in the US community-based practice

Study Type

OBSERVATIONAL

Enrollment

362

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Interventions

MavacamtenDRUG

According to the product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Phase I: retrospective chart review For inclusion in the study, participants must meet ALL of the following criteria: * Are an adult aged 18 or over at baseline * Have a confirmed diagnosis of obstructive hypertrophic cardiomyopathy (HCM) * Have been prescribed mavacamten for obstructive HCM at one of the study sites between 28th April 2022 and 31st December 2024 * Have not ever been enrolled in any interventional clinical trial involving any cardiac myosin inhibitor (enrollment in observational studies is permitted) * Are not enrolled in any interventional clinical trial at study baseline Phase II: patient survey • Participants must meet all inclusion criteria of Phase I: retrospective chart review and be able to read and understand English and have access to computer or smartphone to complete the survey Exclusion Criteria: • None with the proviso that all inclusion criteria are met.

Locations (1)

Adelphi Real World

Bollington, Macclesfield, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Participant blood pressure (both systolic and diastolic)

Group 1 only

Time frame: Baseline

Date of diagnosis of hypertrophic cardiomyopathy

Group 1 only

Time frame: Baseline

Hypertrophic cardiomyopathy genetic testing results

Group 1 only

Time frame: Baseline

Family history of hypertrophic cardiomyopathy

Group 1 only

Time frame: Baseline

Family history of Sudden Cardiac Death (SCD)

Group 1 only

Time frame: Baseline

Participant comorbidities (cardiovascular and non-cardiovascular )

Group 1 only

Time frame: Baseline

Type of prior surgeries and procedures

Group 1 only. Prior surgeries and procedures include: Septal Reduction Therapy (SRT), surgeries (valve repair/placement, left atrial appendage ligation), placement of devices (Implantable Cardioverter Defibrillator (ICD), pacemaker and cardiac resynchronization therapy) or atrial fibrillation/flutter ablation

Time frame: Baseline and up to week 24

Participant New York Heart Association (NYHA) class category

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Change in participant New York Heart Association (NYHA) class from baseline

Central Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Baseline, and at weeks 4, 8, 12, 24

Duration of mavacamten treatment

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Number of mavacamten dose titrations

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Type of mavacamten dose tritration

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Clinical reason for mavacamten dose titration

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Clinical reason for mavacamten treatment discontinuation

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten discontinuation if discontinued due to LVEF<50%,

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Time from mavacamten discontinuation to Left Ventricular Ejection Fraction (LVEF) recovery

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Clinical reason for temporary mavacamten treatment interuption

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Time to temporary mavacamten treatment interruption

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten interruption if the interruption was due to LVEF<50%

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Time from mavacamten treatment interruption to Left Ventricular Ejection Fraction (LVEF) recovery

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Time to mavacamten treatment resumption

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Type of hypertrophic cardiomyopathy (HCM) background therapy prescribed

Group 1 only

Time frame: Baseline, and at weeks 4, 8, 12, 24

Type of changes to hypertrophic cardiomyopathy (HCM) background therapy

Group 1 only. Type of changes include initiation, switching, discontinuation, augmentation, dose titration

Time frame: At baseline, weeks 4, 8, 12, 24

Secondary Outcomes

Perspectives on treatment preference, and the eligibility, onboarding and implementation of mavacamten as assessed by feedback collated through structured physician interviews

Group 2 only

Time frame: Up to week 24