Exercise Training in Patients With Hypertrophic Cardiomyopathy

Hypertrophic Cardiomyopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01518114
• Other study ID #: SHEBA-10-8081-MA-CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2012
• Last updated: January 26, 2012
• Start date: December 2011

Study information

• Verified date: January 2012
• Source: Sheba Medical Center
• Contact: Arad Michael, MD
• Email: Michael.Arad[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer , Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 months	No
Primary	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	12 months	Yes
Secondary	Secondary Endpoints:	The effect on quality of life; The change in maximal wall thickness, LVEF, resting and exercise-induced left ventricular outflow gradient and pulmonary artery pressure (stress echo).; Resting BNP and troponin I levels	12 months	No