Status:
TERMINATED
Rehabilitation in Patients With Congenital Heart Disease
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Heart Defects, Congenital
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Exercise intolerance is a major burden for patients with complex congenital heart disease (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing provides a reliable too...
Detailed Description
This is a randomized, prospective, multicenter, interventional study. After study patients have given written consent they will be randomized either in the interventional group with a rehabilitation ...
Eligibility Criteria
Inclusion
- Patients with complex CHD including cyanotic heart disease, subaortic right ventricle physiology, single ventricle physiology, Ebstein anomaly with ≥ moderate tricuspid regurgitation and patients with Tetralogy of Fallot (including those with pulmonary atresia of Fallot type or double-outlet right ventricle of Fallot type) and either residual free pulmonary regurgitation or left- or right ventricular systolic dysfunction (demonstrated by echocardiography or cardiac MRI).
- Peak VO2 \< 85% of predicted (standardized for age, gender, weight and height) obtained by cardiopulmonary exercise testing
- Sedentary lifestyle (\< 30 minutes of regular exercise per week)
Exclusion
- Patients with dyspnea New York Heart Association (NYHA) class IV.
- Severe left ventricular outflow tract obstruction.
- Unstable angina or recent myocardial infarction (\<12 months).
- Uncontrolled ventricular arrhythmia.
- Recent intervention (\<12 months)
- Life expectancy \<12 months
- No consent.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01463800
Start Date
May 1 2011
End Date
January 1 2017
Last Update
October 2 2017
Active Locations (4)
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1
Virgen Macarena University Hospital
Seville, Spain
2
University Hospital Basel
Basel, Switzerland, 4052
3
Inselspital Bern
Bern, Switzerland, 3010
4
University Hospital Zurich
Zurich, Switzerland, 8091