Hypertrophic Cardiomyopathy
Conditions
Keywords
Hypertrophic Cardiomyopathy, Exercise Training, Cardiac Rehabilitation, Heart Failure
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.
Interventions
BEHAVIORALExercise Training
Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.
Sponsors
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hypertrophic Cardiomyopathy * NYHA 3 * Maximal left ventricular wall thickness \> 20 mm * Age \>18
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoints: | 12 months | 1. The effect on quality of life 2. The change in maximal wall thickness, LVEF, resting and exercise-induced left ventricular outflow gradient and pulmonary artery pressure (stress echo). 3. Resting BNP and troponin I levels |
Countries
Israel
Contacts
Primary ContactArad Michael, MD
Backup ContactRobert Klempfner, MD
Outcome results
None listed