Rehabilitation in Patients With Congenital Heart Disease (CARE-GUCH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01463800
First received: October 28, 2011
Last updated: November 1, 2011
Last verified: October 2011
  Purpose

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 tool both for assessing exercise capacity of CHD patients and for risk stratification and is becoming part of the routine clinical assessment of these patients. Exercise has an effect on the muscular, metabolic and circulatory systems. While exercise training has been widely studied in chronic heart failure, its efficacy in adults with CHD remain unknown. The investigators hypothesize that structured exercise training will improve exercise intolerance, in particular peak VO2. The aim of this multicenter, randomized study is to evaluate the impact of structured exercise training on exercise intolerance in patients with complex CHD.


Condition Intervention
Heart Defects, Congenital
Behavioral: Structured exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Cardiac Rehabilitation in Patients With Complex Congenital Heart Disease: Improvement of Exercise Intolerance

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • peak VO2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Comparison between both gropus


Secondary Outcome Measures:
  • 6 minute walk test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    between both groups and within groups

  • VE/VCO2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Comparison between groups and within groups

  • heart rate response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Difference between peak heart rate and resting heart rate Comparison between groups and within groups

  • QoL [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Comparison between groups and within groups Minnesota Heart failure Score and SF 36

  • BNP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Comparison between groups and within groups

  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    cardiac related adverse events including cardiac death

  • peak VO2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparison between groups and within groups

  • VE/VCO2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparison between groups and within groups

  • Heart rate response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparison between groups and within groups

  • 6 minute walk test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparison between groups and within groups

  • QoL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparison between groups and within groups

  • BNP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparison between groups and within groups

  • Cardiac adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparison between groups and within groups


Estimated Enrollment: 166
Study Start Date: May 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Structured Exercise training
12 weeks ambulatory low level exercise training
Behavioral: Structured exercise training
12 weeks low level ambulatory structured exercise training
No Intervention: Control group
No structured exercise training

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 program or in the control group without rehabilitation program. Patients who are randomized in the control group are allowed to perform the rehabilitation program 12 months after randomisation. Patients in the interventional group will perform structured exercise training on 3 weekdays during a 12-weeks period. Training will be performed by ergometer and low-impact gymnastic and relaxation training.

All study participants have the following investigations at the beginning of the study and after 12 weeks:

  • Cardiopulmonary exercise testing with spirometry
  • 6-minute walk test
  • Blood work: BNP, Creatinine, Sodium, Potassium, Urat, Cholesterol (HDL-L and LDL-L)
  • Validated Heart failure questionnaires (SF-36 and Minnesota Living with heart failure questionnaire, German version for Basel, Zürich and Bern) All tests will be repeated as clinically indicated in a follow-up visit 12 months after baseline

Primary outcome is:

Comparison of peak VO2 at the end of rehabilitation between both groups.

Secondary outcomes are:

  • Comparison of 6-min walk test, VE/VCO2 slope, anaerobic threshold and heart rate and blood pressure response after rehabilitation between both groups
  • Changes of 6-min walk test, peak VO2, VE/VCO2 slope, anaerobic threshold and heart rate and blood pressure response at the end and 12 months after rehabilitation.
  • Changes of quality-of-life assessed by validated heart failure questionnaire at the end and 12 months after rehabilitation and comparison between both groups.
  • Changes of levels of brain-natriuretic peptide at the end and 12 months after rehabilitation.
  • Adverse events during rehabilitation including new onset of arrhythmia, admission due to worsening heart failure or death.

The calculated sample size to reach a power of 0.80 is 83 patients in each arm. Patients with complex CHD and exercise intolerance are at increased risk for premature death and severe cardiac complications including arrhythmia needing treatment, heart failure and circulatory failure, pulmonary hemorrhage, pulmonary embolism and endocarditis. Hence, the likelihood of major adverse cardiac events during the study phase is considerably high. However, there is no evidence of functional worsening by low-level exercise. Smaller studies with patients with congenital heart disease and/or pulmonary hypertension did not report safety issues. Although sudden cardiac death is one of the leading modes of death in this population, it is extremely rare that sudden death occurs during exercise. Cardiac patients who are at specific risk for exercise-induced arrhythmia are not included into the study (i.e. patients with hypertrophic obstructive cardiomyopathy).

  Eligibility

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

Inclusion Criteria:

  1. 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).
  2. Peak VO2 < 85% of predicted (standardized for age, gender, weight and height) obtained by cardiopulmonary exercise testing
  3. Sedentary lifestyle (< 30 minutes of regular exercise per week)

Exclusion Criteria:

  1. Patients with dyspnea New York Heart Association (NYHA) class IV.
  2. Severe left ventricular outflow tract obstruction.
  3. Unstable angina or recent myocardial infarction (<12 months).
  4. Uncontrolled ventricular arrhythmia.
  5. Recent intervention (<12 months)
  6. Life expectancy <12 months
  7. No consent.
  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: NCT01463800

Contacts
Contact: Daniel Tobler, MD +41615565840 toblerd@uhbs.ch

Locations
Spain
Virgen Macarena University Hospital Not yet recruiting
Sevilla, Spain
Contact: Pastora Gallego, MD       pgallgogv@no.com   
Principal Investigator: Pastora Gallego, MD         
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4052
Contact: Daniel Tobler, MD       toblerd@hbs.ch   
Principal Investigator: Daniel Tobler, MD         
Sub-Investigator: Hoffmann Andreas, MD         
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Markus Schwerzmann, MD    +41316327859      
Principal Investigator: Markus Schwerzmann, MD         
Sub-Investigator: Kerstin Khattab, MD         
University Hospital Zurich Not yet recruiting
Zurich, Switzerland, 8091
Contact: Matthias Greutmann, MD       matthias.greutmann@usz.ch   
Principal Investigator: Matthias Greutmann, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Daniel Tobler, MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01463800     History of Changes
Other Study ID Numbers: CARE-GUCH
Study First Received: October 28, 2011
Last Updated: November 1, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Heart Defects, congenital

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Diseases
Cardiovascular Abnormalities

ClinicalTrials.gov processed this record on October 02, 2014