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:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT01291069
Eligibility Criteria:
Inclusion Criteria:
* Patients who have undergone the Fontan procedure (regardless of type of Fontan connection or presence or absence of a fenestration)
* Age 8.0 to 35.0 years
* Stable clinical condition over the last 3 months (i.e. No change in medication, treatments, or development of new symptoms)
* Ability to perform exercise testing
* Consent and assent (as appropriate to participate in the study after receiving information concerning procedures, risks, and possible clinical benefits) o Patients will be enrolled without regard to gender, race, and ethnicity. All patients meeting study eligibility will be approached for consent.
Exclusion Criteria:
* Severe heart failure (New York Heart Association functional class III or IV)
* Presence of liver or renal dysfunction based on the latest lab test results
* Presence of hearing or visual deficit
* Transcutaneous arterial blood oxygen saturation (SaO2) \<80% at rest
* History of echocardiographic, MRI, or angiographic evidence of Fontan pathway obstruction
* History of exercise-induced life-threatening arrhythmias or unstable rhythm(i.e. atrial flutter)
* Known or suspected pregnancy. Females in the reproductive age group will be screened for pregnancy using serum beta hCG prior to administering study drug.
* Patients on open label sildenafil or tadalafil
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
35 Years
Study:
NCT01291069
Study Brief:
Protocol Section:
NCT01291069