Recruiting

Camzyos

Sponsor:

Bristol-Myers Squibb

Code:

NCT06551129

Conditions

Obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mavacamten

Study Details

Brief summary:

This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.

Conditions

Obstructive Hypertrophic Cardiomyopathy

Study ID

NCT06551129

Start date

May 10, 2024

Status verified date

Nov, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants ≥18 years of age.
  • Participants who are prescribed mavacamten for obstructive hypertrophic cardiomyopathy
  • Provided informed consent to participate in the study

Exclusion Criteria:

  • Previously or currently enrolled in clinical trials for any cardiac myosin inhibitors
  • Treated for >7 days with mavacamten by the day of completing the baseline survey
  • Enrolled in any clinical trials at the time of or within the six-month period prior to the screening
  • Had heart attack requiring coronary artery bypass grafting within the three-month period prior to the screening
  • Had stroke or transient ischemic attack within the six-month period prior to the screening
  • Had moderate-to-severe lung disease which impacted the ability to perform daily activities of living and ability to breathe
  • Had major lung (thoracic) or heart (cardiac) surgery within the six-month period prior to the screening
  • Scheduled for a major surgery for the next three months, such as joint surgeries including hip replacement, abdominal surgeries, lung surgeries, heart surgeries, eye surgeries, brain surgeries, and any other major surgeries that require general anesthesia and at least an overnight hospital stay
  • Hospitalized requiring an overnight stay at the time of or within the two-week period prior to the screening

Study Design

Enrollment

118 participants

Anticipated

Interventions and Outcome Measures

Arms

Mavacamten

Adult participants with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten

Interventions

Mavacamten

As prescribed by treating physician

Primary outcome measure

  • Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version) [ Time Frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96 ]
  • Participant physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, QoL, and social limitations as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23) [ Time Frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96 ]
  • Participant mavacamten treatment status [ Time Frame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96 ]
  • Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM) [ Time Frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96 ]
  • Participant symptom severity as assessed by self-assessed New York Heart Association (SA-NYHA) functional class [ Time Frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96 ]
  • Participant change in symptom severity as assessed by Patient Global Impression of Change (PGI-C) [ Time Frame: Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96 ]
  • Participant septal reduction therapy [ Time Frame: Baseline and weeks 12, 30, 48 and 96 ]
  • Participant major injury or surgery since previous survey [ Time Frame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96 ]
  • Participant survey response on experience with CAMZYOS Risk Evaluation and Mitigation Strategy program (REMS) Program [ Time Frame: Baseline and weeks 4, 12, 30, 48, 72 and 96 ]
  • Participant medical history [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

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

Locations

Analysis Group Inc.

Recruiting

Boston, Massachusetts, United States, 02199

Contacts

Min Yang, Site 0001

COMPASS@analysisgroup.com

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Nov 7, 2024

Last verified

Nov, 2024

Keywords

  • Obstructive Hypertrophic cardiomyopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2024-11-07.