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NCT Number: NCT05818605

Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy

The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. About 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions. Patients will be followed during a period of 24 weeks and assesesments as physical examination, questionnaires, 12 lead ecg's, biomarker levels, echocardiogram, Cardiac Magnetic resonance, PET and CPET will be performed to evaluate their response to the intervention.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California - San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Cynthia Partida-Higuera, CCRP

CONTACT

[email protected]

415-514-1125

Theodore P Abraham, M.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall thickness 15 mm or greater on 2D echocardiography in the absence of other primary causes of left ventricular hypertrophy or wall thickness between 13 and 15 mm in the presence of other features suggestive of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
  • Left ventricular outflow tract gradient <30 mmHg at rest and with provocation.
  • Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.
  • Access to exercise equipment at home or at a fitness center.
  • Ability to complete study related testing including online surveys and smart phone use
  • Ability to perform 24 weeks of exercise training

Exclusion criteria

  • History of exercise-induced syncope or ventricular arrhythmias
  • LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
  • History of septal reduction therapy - surgery or ablation
  • History of ICD placement in the previous 3 months
  • History of hypotensive response with exercise testing (>20 mm Hg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure >20 mm Hg)
  • Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms or Canadian Cardiovascular Society class IV angina symptoms
  • Left ventricular ejection fraction less than 50% by echocardiography
  • Life expectancy less than 12 months
  • Pregnant or planned pregnancy
  • Inability to exercise owing to any medical or other limitations
  • Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study, if assigned to the non-exercise group.

Treatment and study plan

Moderate Intensity Exercise Program

Behavioral

Subjects randomized to the EXER arm will undergo 24 weeks of Moderate Intensity Exercise Training (MIET). Patients will be signed up for 60-minute exercise sessions, 3 times a week

Primary outcomes

  1. Change in V O2 max

    Time frame: Baseline and 24 weeks

    Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET

  2. Change in peak VO2 %

    Time frame: Baseline and 24 weeks

    Change in peak VO2 % predicted (%) by CPET

Secondary outcomes

  1. Change in Myocardial Systolic Strain

    Time frame: Baseline and 24 Weeks

    Change in Myocardial systolic strain (%) by echocardiography

  2. Change in Myocardial Work

    Time frame: Baseline and 24 weeks

    Change Myocardial work (mmHg%) by echocardiography

Other outcomes

  1. Change in Myocardial Perfussion

    Time frame: Baseline and 24 Weeks

    Change in Regional myocardial perfusion (ml/min/gm) by PET

  2. Change in Coronary Flow reserve

    Time frame: Baseline and 24 Weeks

    Change in coronary flow reserve (ratio, no unit) by PET

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Partida-Higuera, CCRP

CONTACT

[email protected]

415-514-1125

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

The EXerCise traIning To rEcovery in HCM Trial

Acronym: EXCITE-HCM

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2023
Registry last updated
Nov 20, 2025

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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