Status:
COMPLETED
Cardiovascular, Pulmonary and Skeletal Muscle Evaluation Postoperative in Fontan Patients: Effects of Exercise Training
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Congenital Heart Disease
Single Ventricle
Eligibility:
All Genders
12-30 years
Phase:
NA
Brief Summary
Introduction: The Fontan operation is the surgical treatment in most patients with either anatomic or functional single ventricles. In this operation, the subpulmonary ventricle is bypassed, connectin...
Detailed Description
All subjects were submitted to cardiovascular magnetic resonance, echocardiography, cardiopulmonary exercise test, complete lung function, catecholamine and B-type natriuretic peptide (BNP) plasmatic ...
Eligibility Criteria
Inclusion
- Both gender, aged between 12 and 30 years
- Patients undergoing the Fontan operation with time postoperatively ≥5 years
- Clinically stable patients, no arrhythmia in the last electrocardiogram or clinical assessment
- Consent by the cardiologist
- Patients who voluntarily signed the consent form.
Exclusion
- Patients with hypoplastic left heart syndrome
- Changes that reduce musculoskeletal walking skills
- Neurological sequelae, patients with associated genetic syndrome, disturbance cognitive or psychiatric
- Patients with a history of ventricular arrhythmias, cardio respiratory arrest, users of anti-arrhythmic drugs and / or underwent implantation of pacemaker
- Atrial arrhythmia requiring treatment in the last 6 months
- Patients with heart failure not controlled by medications and lung hypertension
- Patients with protein-losing enteropathy
- Severe hypoxemia (oxygen saturation \<80% at rest)
- Symptomatic patients with a diagnosis of diaphragmatic paresis or paralysis postoperative patients, with or without plication
- Patients with moderate to severe asthma
- Patients who live outside the area of Sao Paulo
Key Trial Info
Start Date :
January 31 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02283255
Start Date
January 31 2013
End Date
October 30 2020
Last Update
December 7 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
InCor Heart Institute
São Paulo, Brazil, 05403000