Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Theodore P Abraham, M.D
Headshot of Theodore P Abraham
Theodore P Abraham

Description

Summary

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.

Official Title

The EXerCise traIning To rEcovery in HCM Trial

Keywords

Hypertrophic Cardiomyopathy, Cardiomyopathies, Hypertrophy, Moderate Intensity Exercise Program

Eligibility

You can join if…

Open to people ages 18-80

  1. 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.
  2. Left ventricular outflow tract gradient <30 mmHg at rest and with provocation.
  3. Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.
  4. Access to exercise equipment at home or at a fitness center.
  5. Ability to complete study related testing including online surveys and smart phone use
  6. Ability to perform 24 weeks of exercise training

You CAN'T join if...

  1. History of exercise-induced syncope or ventricular arrhythmias
  2. LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
  3. History of septal reduction therapy - surgery or ablation
  4. History of ICD placement in the previous 3 months
  5. 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)
  6. 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
  7. Left ventricular ejection fraction less than 50% by echocardiography
  8. Life expectancy less than 12 months
  9. Pregnant or planned pregnancy

    10. Inability to exercise owing to any medical or other limitations 11. 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.

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Theodore P Abraham, M.D
    My are echocardiography and hypertrophic cardiomyopathy (HCM). I direct the UCSF Echocardiography laboratory and co-direct the UCSF HCM Center of Excellence. I have expertise in transthoracic, stress and transesophageal echocardiography. I also have training and expertise in 3D and strain echocardiography.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05818605
Study Type
Interventional
Participants
Expecting 70 study participants
Last Updated