An interventional study of Exercise Intervention and Physical Activity Handout in Hypertrophic Cardiomyopathy (HCM), sponsored by Oregon Health and Science University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment
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.
Habitual exercise has been shown to improve longevity and reduce mortality. Patients with HCM often have reduced exercise tolerance as the disease progresses. Cardiopulmonary exercise testing (CPET) is often performed to assess quantitative exercise capacity in clinical testing, but questions remain on normative values and how to accurately predict prognosis in individuals with HCM. Peak oxygen consumption (peak VO2) measured by CPET is the gold standard for assessing cardiorespiratory fitness and is an important prognostic marker in cardiovascular health. Prior RCTs have demonstrated that 12 to 20 weeks of exercise training can safely improve peak VO2, hemodynamics, and quality of life in selected patients with HCM. However, existing exercise trials have not included individuals actively treated with CMIs, which represent an emerging standard of care. Further, these exercise intervention trials have not universally included resistance training, despite recommendations in current guidelines. This study aims to evaluate whether an individualized exercise regimen combining endurance and resistance training provides additive improvements in exercise capacity and quality of life for HCM patients on aficamten.
363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Browse Cardiomyopathy, Hypertrophic studies →Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the intervention arm will be prescribed a training plan and provided with a gym membership including personal training sessions. Participants will also be given a smartwatch and chest strap to track physical activity.
Behavioral: Exercise Intervention
Participants randomized to the control arm will be receive a Physical Activity Recommendations Handout and a smartwatch to track physical activity.
Behavioral: Physical Activity Handout
A 3-month training plan with a gym membership including weekly personal training sessions. Subjects will also be given a Garmin Forerunner 55 smartwatch and Garmin HRM 200 chest strap to track heart rates during exercise.
An American Heart Association Physical Activity Recommendations handout will be provided, and a Garmin Forerunner 55 smartwatch will be given to subjects to wear during waking hours over 3-month period.
Peak oxygen consumption (Peak VO2)
CPET performed at baseline and 12-weeks, following the exercise intervention will be used to measure aerobic capacity, peak VO2. The change in peak VO2 from baseline to 12 weeks is the primary outcome measure.
Time frame: 12 weeks
Ventilatory Efficiency (VE/VCO2 Slope)
Ventilatory efficiency is defined as the slope of minute ventilation to carbon dioxide production (VE/VCO2) and will be evaluated via CPET performed at baseline and at 12-weeks. A lower slope indicates improved ventilatory efficiency.
Time frame: 12 weeks
Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)
Quality of life questionnaire scaled from 0 to 100, where higher scores indicate better health status. This will be recorded at baseline and 12-weeks. An increase of 5 points is considered a clinically meaningful increase.
Time frame: 12 weeks
Short Form - 36 (SF-36)
The SF-36 is a general health survey to assess overall physical and mental health domains. Scores on each scale range from 0 to 100, with higher scores representing better health-related quality of life and higher overall functional capacity.
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: Yes — A limited access dataset generated from this project will rapidly be made available to the broader community for distribution to outside researchers according to established Oregon Health \& Science University policies. Exercise training plans developed as part of the study will be made available.
Supporting information: Study protocol
Start is estimated for Sep 2026; primary completion for Jul 2028, 22 months later.
Of 47 non-industry interventional studies with no phase under Cardiomyopathy, Hypertrophic, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 60. This study's planned 22 months is below that.
Counting every sponsor, half of 52 studies reached it within 52 months; a quarter within 26 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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