Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05818605
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Feb 17, 2023
Status verified
Nov 2025
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Moderate Intensity Exercise arm
    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.
  • No Intervention: Usual physical activity arm
    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

Primary Outcome Measure

Change in V O2 max [ Time Frame: Baseline and 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California - San FranciscoSan FranciscoCalifornia94143
Cynthia Partida-Higuera, CCRP
[email protected]
415-514-1125
Theodore P Abraham, M.D (PRINCIPAL_INVESTIGATOR)

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By research site
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