Exercise Training in Patients With Hypertrophic Cardiomyopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Michael Arad, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01518114
First received: January 10, 2012
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Hypertrophic Cardiomyopathy
Behavioral: Exercise Training

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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • Secondary Endpoints: [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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.
Active Comparator: Best Medical Care
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518114

Contacts
Contact: Arad Michael, MD Michael.Arad@sheba.health.gov.il
Contact: Robert Klempfner, MD +972525506852 klempfner@gmail.com

Locations
Israel
Sheba Medical Center Recruiting
Tel Hashomer , Ramat Gan, Israel
Contact: Robert Klempfner, MD    +972525506852    klempfner@gmail.com   
Principal Investigator: Arad Michael, MD         
Sub-Investigator: Tamir Kamerman, MS         
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Michael Arad, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01518114     History of Changes
Other Study ID Numbers: SHEBA-10-8081-MA-CTIL
Study First Received: January 10, 2012
Last Updated: January 26, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Hypertrophic Cardiomyopathy
Exercise Training
Cardiac Rehabilitation
Heart Failure

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases

ClinicalTrials.gov processed this record on September 18, 2014