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NCT07835854
Individualized Exercise Training in Hypertrophic Cardiomyopathy
Conditions: Hypertrophic Cardiomyopathy (HCM)
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Oregon Health and Science University
Summary
Exercise intervention trials in patients with hypertrophic cardiomyopathy (HCM) have demonstrated an association with improvement in resting and exercise hemodynamics, ventricular remodeling, and anxiety/depression. However, no randomized controlled trials (RCTs) to date have assessed the effects of exercise intervention in patients with HCM on cardiac myosin inhibitors (CMIs). This trial aims to evaluate the efficacy of a 12-week individualized exercise training program in HCM patients receiving aficamten.
Eligibility Criteria
Inclusion Criteria:
* Age 18-80 years.
* Clinical diagnosis of HCM.
* Able to perform endurance and resistance exercise.
* Currently on stable dose of aficamten
* Not meeting current guideline recommended physical activity recommendations (150-300 minutes of moderate-vigorous physical activity/week, strength training ≥2 times weekly).
* Adequate clinical stability has been achieved (in the judgment of the investigator) to allow participation in study assessments and intervention.
* Signed informed consent indicating that the patient understands the purpose of the study, the procedures required and is willing to participate.
Exclusion Criteria:
* Residual left ventricular outflow tract obstruction (peak gradient ≥50mmHg at rest).
* Sustained ventricular arrhythmias or ICD shock within 6 months.
* Pregnancy.
* Severe valvular stenosis.
* Large pericardial effusion.
* Recent acute myocarditis (\< 3 months).
* Recent acute coronary syndrome or coronary artery bypass \< 6 months.
* Recent cardiac medication changes for management of cardiomyopathy.
* Patients with investigational intracardiac devices.
Source: ClinicalTrials.gov (NCT07835854). StuddyBuddy aggregates publicly available trial information.