Recruiting NCT07600177
Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
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: Aficamten.
- Who it may be relevant to
- Registry conditions: Hypertrophic Cardiomyopathy (HCM). Basic parameters: 18 years — 90 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 States
- 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 →
Overview
This is an investigator-initiated two-center study. The goal of this study is to investigate the feasibility, safety and efficacy outcomes of a seamless transition from mavacamten to aficamten in patients with obstructive hypertrophic cardiomyopathy (oHCM).
Interventions
- Drug Aficamten
Patients will be switched from mavacamten to aficamten. Mavacamten will be stopped at enrollment, and aficamten started 2 weeks later.
Primary outcome measures
- Safety Endpoints [Time frame: Up to 16 weeks]
Secondary outcome measures (4)
- Proportional change from baseline in resting and Valsalva LVOT gradients during each assessment [Time frame: Up to 16 weeks]
- Proportion of participants with resting LVOT gradient < 30 mmHg and Valsalva LVOT gradient < 50 mmHg [Time frame: Up to 16 weeks]
- Proportional change from baseline in NT-proBNP and high-sensitivity troponin I [Time frame: Up to 16 weeks]
- Proportional improvement in NYHA functional classification by 1 functional class [Time frame: Up to 16 weeks]
Eligibility criteria
Inclusion criteria
- Documented history of oHCM with documented resting and/or Valsalva LVOT obstruction ≥ 50 mmHg who are currently receiving mavacamten commercially.
- Echo-derived LVEF ≥55% on mavacamten at the time of enrollment.
- Patient willing to consent for the study and undergo the study procedures.
Exclusion criteria
- Severe aortic stenosis or sub-aortic obstruction
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
- History of LVEF <30%.
- Paroxysmal atrial fibrillation (AF) with documented episode within 3 months.
- Atrial fibrillation (paroxysmal or permanent) not on systemic anticoagulation.
- Documented history of current obstructive coronary artery disease (> 70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- St. Luke's Hospital - Mid America Heart Institute — Kansas City
- Oregon Health & Science University — Portland
Identifiers
NCT: NCT07600177 · STUDY00029878 · 007119