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

January 19, 2016 updated by: Rambam Health Care Campus
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparing Cardio Pulmonary Exercise function between the three groups in the study
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

November 22, 2015

First Submitted That Met QC Criteria

January 19, 2016

First Posted (ESTIMATE)

January 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0124-15-RMB CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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