Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07420660
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a Fontan circulation: individuals who have undergone the Fontan procedure with only one functioning systemic ventricle, confirmed by medical records or attending physician.
* Stable clinical status: patients should be clinically stable without significant cardiovascular or renal dysfunction as determined by clinical examinations.
* Age range: 16-50 years.
* Ability to exercise: Participants must be physically able to participate in the exercise protocol according to a preliminary medical examination.
Controls: Age and sex-matched. Healthy (no chronic diseases, assessed by health questionnaire and interview).
Exclusion Criteria:
* Recent surgery or hospitalization: individuals who have undergone cardiovascular surgery or hospitalization within six months prior to inclusion.
* Severe functional limitations: Patients with clear functional limitations unrelated to Fontan physiology, such as musculoskeletal disorders.
* Significant comorbidities: Serious non-cardiac comorbidities that may independently affect work capacity, such as advanced pulmonary disease.
* Contraindications for exercise testing: Conditions that contraindicate physical testing, such as uncontrolled cardiac arrhythmias or severe heart failure (New York Heart Association III-IV).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT07420660
Study Brief:
Protocol Section:
NCT07420660