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NCT Number: NCT07835854

Individualized Exercise Training in Hypertrophic Cardiomyopathy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise Intervention

Behavioral

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.

Physical Activity Handout

Behavioral

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.

Primary outcomes

  1. Peak oxygen consumption (Peak VO2)

    Time frame: 12 weeks

    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.

  2. Ventilatory Efficiency (VE/VCO2 Slope)

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)

    Time frame: 12 weeks

    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.

  2. Short Form - 36 (SF-36)

    Time frame: 12 weeks

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Graded Exercise Training For Individualized Treatment in Hypertrophic Cardiomyopathy: GET-FIT Hypertrophic Cardiomyopathy Study

Acronym: GET-FIT HCM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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