Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial population
The study population will consist of adults that have been diagnosed with obstructive hypertrophic cardiomyopathy (HCM) and have received treatment with mavacamten and their treating clinicians from participating community-based sites in the US.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Mavacamten
DrugAccording to the product label
Treatment groups
362 Participants
are divided into 2 treatment groupsGroup A: Group 11 intervention
Group B: Group 21 intervention
Trial outcomes
Primary outcomes
1
Participant blood pressure (both systolic and diastolic)
Group 1 only
Time frame
Baseline2
Date of diagnosis of hypertrophic cardiomyopathy
Group 1 only
Time frame
Baseline3
Hypertrophic cardiomyopathy genetic testing results
Group 1 only
Time frame
Baseline4
Family history of hypertrophic cardiomyopathy
Group 1 only
Time frame
BaselineSecondary outcomes
1
Perspectives on treatment preference, and the eligibility, onboarding and implementation of mavacamten as assessed by feedback collated through structured physician interviews
Group 2 only
Time frame
Up to week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov