Examining factors affecting fitness in patients who had the Fontan procedure
Official title: Pulmonary Determinants of Cardiorespiratory Fitness in Patients With Fontan Procedure
Run by Hacettepe University · NCT05684562 · Data updated 2026-11-12
This study looks at how lung function affects fitness in people who have had the Fontan procedure for congenital heart disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 8 Years to 55 Years |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | Hacettepe University Academic / other |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | December 26, 2023 |
| Main results expected | December 25, 2026 |
| Study ends | April 30, 2027 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT05684562 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 8-55 who have undergone the Fontan operation and are clinically stable.
✕Probably not a fit
Patients with neurological, genetic, or orthopedic issues that prevent testing may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the pulmonary determinants of cardiorespiratory fitness in patients who have undergone the Fontan procedure for congenital heart disease. It will involve the collection of medical records and routine evaluations, including physical examinations and various tests such as cardiopulmonary exercise tests and pulmonary function tests. No additional interventions or changes in treatment will be made as part of this study, focusing solely on existing patient data and routine assessments. The goal is to better understand the relationship between pulmonary function and fitness in this specific patient population.
Why it matters
Potential benefit: If successful, this study could provide insights that improve the management and rehabilitation of Fontan patients, enhancing their quality of life.
How similar studies have gone: While similar studies have explored aspects of fitness in congenital heart disease, this specific focus on pulmonary determinants in Fontan patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Fontan Group Inclusion Criteria: * Be between 8-55 years old * Having undergone a Fontan operation * Clinical stability of the patients (preserved ventricular function) * No change in ongoing drug therapy that adversely affects clinical stability * At least 1 year after the operation Fontan Group Exclusion Criteria: * Neurological and/or genetic musculoskeletal disease * Having orthopedic and cognitive problems that prevent testing * The patient's and/or family's unwillingness to participate in the study Control Group Inclusion Criteria: * Not have cardiovascular, neurological, and/or genetic musculoskeletal disease * Not having orthopedic and cognitive problems that prevent testing * The patient's and/or family's willingness to participate in the study
Where it's running
-
Hacettepe Unıversity
Ankara, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Haluk Tekerlek
- Email: haluktekerlek@gmail.com
- Phone: +905355915009
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.