Examining factors affecting fitness in patients who had the Fontan procedure
Pulmonary Determinants of Cardiorespiratory Fitness in Patients With Fontan Procedure
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 |
|---|---|
| Enrollment | 78 (estimated) |
| Ages | 8 Years to 55 Years |
| Sex | All |
| Sponsor | Hacettepe University Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT05684562 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 8-55 who have undergone the Fontan operation and are clinically stable.
Not a fit: Patients with neurological, genetic, or orthopedic issues that prevent testing may not benefit from this study.
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 performed: While similar studies have explored aspects of fitness in congenital heart disease, this specific focus on pulmonary determinants in Fontan patients is relatively novel.
Eligibility criteria
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 this trial is running
Ankara
- Hacettepe Unıversity — Ankara, Turkey (Recruiting)
Study contacts
- Study coordinator: Haluk Tekerlek
- Email: haluktekerlek@gmail.com
- Phone: +905355915009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.