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

January 10, 2012
January 26, 2012
December 2011
January 2013   (final data collection date for primary outcome measure)
  • 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
  • The change in functional capacity following exercise rehabilitation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    End point to be assessed by cardiopulmonary testing pre- and post exercise training. VO2 MAX, exercise duration, duration to VT - are to be determined and compared to baseline values.
  • 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
Complete list of historical versions of study NCT01518114 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Exercise Training in Patients With Hypertrophic Cardiomyopathy
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hypertrophic Cardiomyopathy
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.
  • 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.

    Intervention: Behavioral: Exercise Training
  • 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.
    Intervention: Behavioral: Exercise Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Arad Michael, MD Michael.Arad@sheba.health.gov.il
Contact: Robert Klempfner, MD +972525506852 klempfner@gmail.com
Israel
 
NCT01518114
SHEBA-10-8081-MA-CTIL
No
Dr. Michael Arad, Sheba Medical Center
Sheba Medical Center
Not Provided
Not Provided
Sheba Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP