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NCT02659462 Clinical Trial

Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.

Congenital Heart Disease Clinical Trial

Official title:
Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02659462
Other study ID # 0124-15-RMB CTIL
Secondary ID
Status Enrolling by invitation
Phase N/A
First received November 22, 2015
Last updated January 19, 2016
Start date October 2015
Est. completion date December 2016

Study information
Verified date January 2016
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

prospective cardio respiratory evaluation for patients post the Fontan palliation for single ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy volunteers in order to evaluate the functional capacity and the primary etiology for reduction in functional capacity.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 45
Est. completion date December 2016
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 25 Years
Eligibility Inclusion Criteria:

- Children at age of 8-25 post fontan palliation

- Patients With Repaired Congenital Heart Disease without chronic lung disease

- Healthy patients ate age of 8-25

Exclusion Criteria:

- Patients with chronic lung disease

- Pregnant women

- Patients with acute active disease or chronic disease that may affect the exercise function

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Cardio Pulmonary Exercise Testing
Cardio Pulmonary Exercise Testing

Locations
Country Name City State
Israel RAMBAM health care center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (2)

American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. Review. Erratum in: Am J Respir Crit Care Med. 2003 May 15;1451-2. — View Citation

Rhodes J, Ubeda Tikkanen A, Jenkins KJ. Exercise testing and training in children with congenital heart disease. Circulation. 2010 Nov 9;122(19):1957-67. doi: 10.1161/CIRCULATIONAHA.110.958025. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Comparing Cardio Pulmonary Exercise function between the three groups in the study one year No
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