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

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ClinicalTrials.gov Identifier: NCT02659462
Recruitment Status : Unknown
Verified January 2016 by Rambam Health Care Campus.
Recruitment status was:  Enrolling by invitation
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

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
Fontan Palliation Congenital Heart Disease Other: Cardio Pulmonary Exercise Testing

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Study Type : Observational
Estimated 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 : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Comparing Cardio Pulmonary Exercise function between the three groups in the study [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659462


Locations
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Israel
RAMBAM health care center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Publications:
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02659462    
Other Study ID Numbers: 0124-15-RMB CTIL
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 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:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities