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

NCT ID: NCT02659462

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-12-31

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.

Conditions

Fontan Palliation; Congenital Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients post Fontan palliation for single ventricular hear

Cardio Pulmonary Exercise Testing

Cardio Pulmonary Exercise Testing

Intervention Type: OTHER

Cardio Pulmonary Exercise Testing

Subjects post surgical correction of congenital heart disease

Cardio Pulmonary Exercise Testing

Cardio Pulmonary Exercise Testing

Intervention Type: OTHER

Cardio Pulmonary Exercise Testing

Healthy patients

Cardio Pulmonary Exercise Testing

Cardio Pulmonary Exercise Testing

Intervention Type: OTHER

Cardio Pulmonary Exercise Testing

Interventions

Cardio Pulmonary Exercise Testing

Cardio Pulmonary Exercise Testing

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RAMBAM health care center

Haifa, , Israel

Countries

Israel

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 21060085 (View on PubMed)

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. doi: 10.1164/rccm.167.2.211. No abstract available.

Reference Type: BACKGROUND

PMID: 12524257 (View on PubMed)

Other Identifiers

0124-15-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id