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
• 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

• Congenital Heart Disease
• Fontan Palliation
• Heart Defects, Congenital
• Heart Diseases

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