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

NCT02659462 | Unknown

• 1 other identifier: 0124-15-RMB CTIL
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Repaired Congenital Heart Disease; Cardio Pulmonary Exercise Testing; Fontan; Fontan Palliation; functional capacity

Outcome Measures

Primary Outcomes (1)

• Comparing Cardio Pulmonary Exercise function between the three groups in the study

  one year

Study Arms (3)

patients post Fontan palliation for single ventricular hear

Cardio Pulmonary Exercise Testing

Other: Cardio Pulmonary Exercise Testing

Subjects post surgical correction of congenital heart disease

Cardio Pulmonary Exercise Testing

Other: Cardio Pulmonary Exercise Testing

Healthy patients

Cardio Pulmonary Exercise Testing

Other: Cardio Pulmonary Exercise Testing

Interventions

Cardio Pulmonary Exercise Testing OTHER

Cardio Pulmonary Exercise Testing

Healthy patients; Subjects post surgical correction of congenital heart disease; patients post Fontan palliation for single ventricular hear

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1. 15 patients post the Fontal palliation for single ventricular heart 2. 15 subjects post surgical correction of congenital heart disease. 3. 15 healthy subjects.

You may qualify if:

• 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

You may not qualify if:

• Patients with chronic lung disease
• Pregnant women
• Patients with acute active disease or chronic disease that may affect the exercise function

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

RAMBAM health care center

Haifa, 31096, Israel

Location

Related Publications (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. No abstract available.

  PMID: 21060085 BACKGROUND

• 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.

  PMID: 12524257 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: January 20, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

IL (1)