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

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02659462
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fontan Palliation; Congenital Heart Disease	Other: Cardio Pulmonary Exercise Testing

Study Design

• Study Type: Observational
• Anticipated Enrollment: 45 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.
• Study Start Date: Oct 1, 2015
• Anticipated Primary Completion Date: Oct 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
patients post Fontan palliation for single ventricular hear Cardio Pulmonary Exercise Testing	Other: Cardio Pulmonary Exercise Testing; Cardio Pulmonary Exercise Testing
Subjects post surgical correction of congenital heart disease Cardio Pulmonary Exercise Testing	Other: Cardio Pulmonary Exercise Testing; Cardio Pulmonary Exercise Testing
Healthy patients Cardio Pulmonary Exercise Testing	Other: Cardio Pulmonary Exercise Testing; Cardio Pulmonary Exercise Testing

Outcome Measures

Primary Outcome Measures

1. Comparing Cardio Pulmonary Exercise function between the three groups in the study [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RAMBAM health care center	Haifa		Israel	31096

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Rambam Health Care Campus
• ClinicalTrials.gov Identifier: NCT02659462
• Other Study ID Numbers: 0124-15-RMB CTIL
• First Posted: Jan 20, 2016
• Last Update Posted: Jan 20, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Rambam Health Care Campus: Repaired Congenital Heart Disease; Cardio Pulmonary Exercise Testing; Fontan; Fontan Palliation; functional capacity
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital

Study Results

No Results Posted as of Jan 20, 2016