Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

NCT06551129 | Recruiting FDA Drug

• 1 other identifier: CV027-1002
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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

Keywords

Obstructive Hypertrophic cardiomyopathy

Outcome Measures

Primary Outcomes (10)

• Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version)

  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)

  Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

• Participant mavacamten treatment status

  Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

• Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM)

  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

  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)

  Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96

• Participant septal reduction therapy

  Baseline and weeks 12, 30, 48 and 96

• Participant major injury or surgery since previous survey

  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

  Baseline and weeks 4, 12, 30, 48, 72 and 96

• Participant medical history

  Baseline

Study Arms (1)

Mavacamten

Adult participants with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten

Drug: Mavacamten

Interventions

Mavacamten DRUG

As prescribed by treating physician

Mavacamten

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants in the United States diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten treatment

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Analysis Group Inc.

Boston, Massachusetts, 02199, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

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

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

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 13, 2024
• Study Start: May 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)