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

Mavacamten Real-World OutcomeS and the Associated PAtient and Physician ExpeRienCe With Hypertrophic CardioMyopathy in the United States (US) Community

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 Overview

• Status: Recruiting
• Conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM)
• Intervention / Treatment: Drug: Mavacamten

• Study Type: Observational
• Enrollment (Estimated): 362

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• United Kingdom
  • Macclesfield
    • Bollington, Macclesfield, United Kingdom, SK10 5JB
      • Recruiting
      • Adelphi Real World
      • Contact: USA Generic Country, Site 0001; Phone Number: 0000000000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults that have been diagnosed with obstructive hypertrophic cardiomyopathy (HCM) and have received treatment with mavacamten and their treating clinicians from participating community-based sites in the US.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Participants with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten	Drug: Mavacamten; According to the product label
Group 2; Physicians treating patients diagnosed with obstructive hypertrophic cardiomyopathy (oHCM)	Drug: Mavacamten; According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant blood pressure (both systolic and diastolic)	Group 1 only	Baseline
Date of diagnosis of hypertrophic cardiomyopathy	Group 1 only	Baseline
Hypertrophic cardiomyopathy genetic testing results	Group 1 only	Baseline
Family history of hypertrophic cardiomyopathy	Group 1 only	Baseline
Family history of Sudden Cardiac Death (SCD)	Group 1 only	Baseline
Participant comorbidities (cardiovascular and non-cardiovascular )	Group 1 only	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	Baseline and up to week 24
Participant New York Heart Association (NYHA) class category	Group 1 only	Baseline, and at weeks 4, 8, 12, 24
Change in participant New York Heart Association (NYHA) class from baseline	Group 1 only	Baseline, and at weeks 4, 8, 12, 24
Duration of mavacamten treatment	Group 1 only	Baseline, and at weeks 4, 8, 12, 24
Number of mavacamten dose titrations	Group 1 only	Baseline, and at weeks 4, 8, 12, 24
Type of mavacamten dose tritration	Group 1 only	Baseline, and at weeks 4, 8, 12, 24
Clinical reason for mavacamten dose titration	Group 1 only	Baseline, and at weeks 4, 8, 12, 24
Clinical reason for mavacamten treatment discontinuation	Group 1 only	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	Baseline, and at weeks 4, 8, 12, 24
Time from mavacamten discontinuation to Left Ventricular Ejection Fraction (LVEF) recovery	Group 1 only	Baseline, and at weeks 4, 8, 12, 24
Clinical reason for temporary mavacamten treatment interuption	Group 1 only	Baseline, and at weeks 4, 8, 12, 24
Time to temporary mavacamten treatment interruption	Group 1 only	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	Baseline, and at weeks 4, 8, 12, 24
Time from mavacamten treatment interruption to Left Ventricular Ejection Fraction (LVEF) recovery	Group 1 only	Baseline, and at weeks 4, 8, 12, 24
Time to mavacamten treatment resumption	Group 1 only	Baseline, and at weeks 4, 8, 12, 24
Type of hypertrophic cardiomyopathy (HCM) background therapy prescribed	Group 1 only	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	At baseline, weeks 4, 8, 12, 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perspectives on treatment preference, and the eligibility, onboarding and implementation of mavacamten as assessed by feedback collated through structured physician interviews	Group 2 only	Up to week 24

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): June 17, 2027

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Obstructive Hypertrophic cardiomyopathy (oHCM)
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathy, Hypertrophic; MYK-461
• Other Study ID Numbers: CV027-1164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No