Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mavacamten.
- Who it may be relevant to
- Registry conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mavacamten Real-World OutcomeS and the Associated PAtient and Physician ExpeRienCe With Hypertrophic CardioMyopathy in the United States (US) Community
Overview
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
Interventions
- Drug Mavacamten
According to the product label
Primary outcome measures
- Participant blood pressure (both systolic and diastolic) [Time frame: Baseline]
- Date of diagnosis of hypertrophic cardiomyopathy [Time frame: Baseline]
- Hypertrophic cardiomyopathy genetic testing results [Time frame: Baseline]
- Family history of hypertrophic cardiomyopathy [Time frame: Baseline]
- Family history of Sudden Cardiac Death (SCD) [Time frame: Baseline]
- Participant comorbidities (cardiovascular and non-cardiovascular ) [Time frame: Baseline]
- Type of prior surgeries and procedures [Time frame: Baseline and up to week 24]
- Participant New York Heart Association (NYHA) class category [Time frame: Baseline, and at weeks 4, 8, 12, 24]
- Change in participant New York Heart Association (NYHA) class from baseline [Time frame: Baseline, and at weeks 4, 8, 12, 24]
- Duration of mavacamten treatment [Time frame: Baseline, and at weeks 4, 8, 12, 24]
Secondary outcome measures (1)
- Perspectives on treatment preference, and the eligibility, onboarding and implementation of mavacamten as assessed by feedback collated through structured physician interviews [Time frame: Up to week 24]
Eligibility criteria
Inclusion criteria
Phase I: retrospective chart review
For inclusion in the study, participants must meet ALL of the following criteria:
- 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)
- Are not enrolled in any interventional clinical trial at study baseline
Phase II: patient survey • Participants must meet all inclusion criteria of Phase I: retrospective chart review and be able to read and understand English and have access to computer or smartphone to complete the survey
Exclusion criteria
- None with the proviso that all inclusion criteria are met.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Adelphi Real World — Bollington
Identifiers
NCT: NCT07557498 · CV027-1164