Exercise Training in Patients With Hypertrophic Cardiomyopathy

Sheba Medical Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypertrophic Cardiomyopathy

Interventions

Exercise TrainingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sheba Medical Center

Tel Hashomer , Ramat Gan, Israel

RECRUITING

Outcomes

Primary Outcomes

Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation

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).

Time frame: 6 months

Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy

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

Time frame: 12 months

Secondary Outcomes

Secondary Endpoints:

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

Time frame: 12 months

Central Contacts

Arad Michael, MD

CONTACT

Michael.Arad@sheba.health.gov.il

Robert Klempfner, MD

CONTACT

+972525506852 klempfner@gmail.com

Data from ClinicalTrials.gov

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