Back to resultsExercise Training in Patients With Hypertrophic Cardiomyopathy
Primary Purpose
Hypertrophic Cardiomyopathy
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Exercise Training
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring Hypertrophic Cardiomyopathy, Exercise Training, Cardiac Rehabilitation, Heart Failure
Eligibility 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.
Sites / Locations
- Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise Training
Best Medical Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01518114
First Posted
January 10, 2012
Last Updated
January 26, 2012
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01518114
Brief Title
Exercise Training in Patients With Hypertrophic Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
Hypertrophic Cardiomyopathy, Exercise Training, Cardiac Rehabilitation, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Best Medical Care
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Exercise Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation
Description
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
Title
Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy
Description
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 Outcome Measure Information:
Title
Secondary Endpoints:
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arad Michael, MD
Email
Michael.Arad@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Klempfner, MD
Phone
+972525506852
Email
klempfner@gmail.com
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer , Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Klempfner, MD
Phone
+972525506852
Email
klempfner@gmail.com
First Name & Middle Initial & Last Name & Degree
Arad Michael, MD
First Name & Middle Initial & Last Name & Degree
Tamir Kamerman, MS
12. IPD Sharing Statement
Learn more about this trial
Exercise Training in Patients With Hypertrophic Cardiomyopathy
We'll reach out to this number within 24 hrs