Health TrialsbyHealthPanel

Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

ConditionObstructive Hypertrophic Cardiomyopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants ≥18 years of age.

Participants who are prescribed mavacamten for obstructive hypertrophic cardiomyopathy

Provided informed consent to participate in the study

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Mavacamten

    Drug

    As prescribed by treating physician

Treatment groups

118 Participants
are divided into 1 treatment group
Group A: Mavacamten1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

Participant mavacamten treatment status

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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