Exercise Training in Patients With Hypertrophic Cardiomyopathy

Not Applicable

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Behavioral: Exercise Training

• Registration Number: NCT01518114
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Status Verified: 2012-01
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-31
• Primary Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Training	Exercise 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. Exercise prescription will be based upon cardiopulmonary test done at baseline.
Best Medical Care	Exercise Training	Advanced HCM patients who are eligible to participate in the study but cannot do so for technical reasons will be invited to participate in the project as a control group.These subjects will continue their regular follow up in the Cardiomyopathy Clinic and their usual voluntary physical activity at home.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel Hashomer , Ramat Gan, Israel