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NCT Number: NCT07557498

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

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

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Key information

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adelphi Real World

Bollington, Macclesfield, SK10 5JB, United Kingdom

Location status: Recruiting

Location contact

USA Generic Country, Site 0001

CONTACT

0000000000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mavacamten

Drug

According to the product label

Primary outcomes

  1. Participant blood pressure (both systolic and diastolic)

    Time frame: Baseline

    Group 1 only

  2. Date of diagnosis of hypertrophic cardiomyopathy

    Time frame: Baseline

    Group 1 only

  3. Hypertrophic cardiomyopathy genetic testing results

    Time frame: Baseline

    Group 1 only

  4. Family history of hypertrophic cardiomyopathy

    Time frame: Baseline

    Group 1 only

  5. Family history of Sudden Cardiac Death (SCD)

    Time frame: Baseline

    Group 1 only

  6. Participant comorbidities (cardiovascular and non-cardiovascular )

    Time frame: Baseline

    Group 1 only

  7. Type of prior surgeries and procedures

    Time frame: Baseline and up to week 24

    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

  8. Participant New York Heart Association (NYHA) class category

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

    Group 1 only

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

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

    Group 1 only

  10. Duration of mavacamten treatment

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

    Group 1 only

  11. Number of mavacamten dose titrations

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

    Group 1 only

  12. Type of mavacamten dose tritration

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

    Group 1 only

  13. Clinical reason for mavacamten dose titration

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

    Group 1 only

  14. Clinical reason for mavacamten treatment discontinuation

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

    Group 1 only

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

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

    Group 1 only

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

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

    Group 1 only

  17. Clinical reason for temporary mavacamten treatment interuption

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

    Group 1 only

  18. Time to temporary mavacamten treatment interruption

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

    Group 1 only

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

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

    Group 1 only

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

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

    Group 1 only

  21. Time to mavacamten treatment resumption

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

    Group 1 only

  22. Type of hypertrophic cardiomyopathy (HCM) background therapy prescribed

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

    Group 1 only

  23. Type of changes to hypertrophic cardiomyopathy (HCM) background therapy

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

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

Secondary outcomes

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

    Time frame: Up to week 24

    Group 2 only

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: SPARC-HCM

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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