Exercise Training in Patients With Hypertrophic Cardiomyopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertrophic Cardiomyopathy
- Sponsor
- Sheba Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation
- Last Updated
- 14 years ago
Overview
Brief Summary
Exercise training (ET) is highly beneficial in heart failure patients and has been suggested to confer significant symptomatic and functional improvements in patients with diastolic dysfunction. Accordingly, the aim of this study was to examine the safety, feasibility of a structured ET program in symptomatic HCM patients.
Investigators
Dr. Michael Arad
MD
Sheba Medical Center
Eligibility Criteria
Inclusion Criteria
- •Hypertrophic Cardiomyopathy
- •Maximal left ventricular wall thickness \> 20 mm
Exclusion Criteria
- •Severe non-cardiac limitations of functional capacity such as neurological illness, lung disease, peripheral vascular or orthopedic problem, etc.
- •Patients state post resuscitation for malignant ventricular arrhythmia.
- •History of effort induced syncope, complex ventricular arrhythmia or atrial fibrillation.
- •An exercise-induced decrease in blood pressure
- •Severe left ventricular outflow obstruction defined as resting outflow gradient \> 50 mmHg on maximal therapy
- •Atrial fibrillation with a poorly controlled ventricular response
- •Advanced hypokinetic stage of HCM defined as LVEF \< 40%
- •Congestive heart failure of angina FC IV according to NYHA or CCS respectively.
Outcomes
Primary Outcomes
Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation
Time Frame: 6 months
End point to be assessed by cardiopulmonary testing are pre- and post exercise training improvement as expressed by the changes in : VO2 MAX, exercise duration, duration to ventilatory threshold(VT).
Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy
Time Frame: 12 months
Safety endpoonts: 1) Clinicaly significant arrhythmia during exercise training 2)MACE during follow-up period (ACS, Stroke or Death) 3)Exercise Related Injury 4) Episodes of syncope
Secondary Outcomes
- Secondary Endpoints:(12 months)