Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy

NCT05818605 | Recruiting DMC

• 1 other identifier: R01HL157238
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Change in V O2 max

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

  Baseline and 24 weeks

• Change in peak VO2 %

  Change in peak VO2 % predicted (%) by CPET

  Baseline and 24 weeks

Secondary Outcomes (2)

• Change in Myocardial Systolic Strain

  Baseline and 24 Weeks

• Change in Myocardial Work

  Baseline and 24 weeks

Other Outcomes (2)

• Change in Myocardial Perfussion

  Baseline and 24 Weeks

• Change in Coronary Flow reserve

  Baseline and 24 Weeks

Study Arms (2)

Moderate Intensity Exercise arm

EXPERIMENTAL

All patients randomized to the exercise training group will undergo a single supervised in-hospital exercise session that includes an exercise consultation with a certified exercise physiologist. Following that they will exercise at-home with video supervision 3 times a week for a period of 24 weeks.

Behavioral: Moderate Intensity Exercise Program

Usual physical activity arm

NO INTERVENTION

Patients randomized to the usual-activity group will be instructed to continue their current activity without initiating or intensifying any existing exercise regimens for the duration of the study

Interventions

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

Moderate Intensity Exercise arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California - San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Theodore P Abraham, M.D

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Partida-Higuera, CCRP

CONTACT

415-514-1125; Cynthia.Partida-Higuera@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, blinded

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 19, 2023
• Study Start: February 17, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)