Obstructive Hypertrophic CardiomyopathyCOMPASS-HCMNCT06551129
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos
An observational study of Obstructive Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- Mavacamten
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2024to 30 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants in the United States diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten treatment
Who may be able to join
- Participants ≥18 years of age.
- Participants who are prescribed mavacamten for obstructive hypertrophic cardiomyopathy
- Provided informed consent to participate in the study
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain NCT # and Site #. contact
United States1 site, 1 recruiting
- Recruiting
Analysis Group Inc.
Boston, Massachusetts, 02199
Min Yang, Site 0001, COMPASS@analysisgroup.com
About this study
Official title: Real-World Camzyos Patient Reported OutcoMes Through PAtient SurveyS in Hypertrophic CardioMyopathy (COMPASS-HCM): A Prospective Longitudinal Study
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
- Being tested
- Mavacamten
- Keywords
- Obstructive Hypertrophic cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavacamtenDrug
As prescribed by treating physician
| Study group | Role | What they receive |
|---|---|---|
| Mavacamten | Adult participants with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version)
Measured: 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)
Measured: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Participant mavacamten treatment status
Measured: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM)
Measured: 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
Measured: 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)
Measured: Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96
Participant septal reduction therapy
Measured: Baseline and weeks 12, 30, 48 and 96
Participant major injury or surgery since previous survey
Measured: 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
Measured: Baseline and weeks 4, 12, 30, 48, 72 and 96
Participant medical history
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start10 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551129
- Sponsor's protocol ID
- CV027-1002
- Acronym
- COMPASS-HCM
- Status last verified
- Nov 2024
- First submitted
- 6 Aug 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No