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:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
NCT ID:
NCT06149806
Eligibility Criteria:
Inclusion Criteria:
* \- Patients ≥ 18 years of age
* Congenital heart disease with systemic right ventricle (D-TGV after atrial switch (Mustard or Senning surgery) or double mismatch), single ventricle of right or left morphology
* Systemic ventricular ejection fraction ≤ 40% (on cardiac magnetic resonance imaging (MRI) less than 12 months old).
In case of contraindication to MRI, LVEF ≤ 40% if systemic left ventricle or surface shortening fraction ≤ 35% if VDS12 (examination less than 12 months old).
* NYHA II or III
* On optimal heart failure therapy: ACE inhibitor or ARB2 for ≥ 4 weeks, at maximum tolerated dose. Whether or not combined with beta-blockers and maximum-tolerated-dose mineralocorticoid receptor antagonists.
* Cardiopulmonary exercise test (CPET) within the last 12 months
Exclusion Criteria:
* \- Other congenital heart disease
* Inability to perform CPETH
* Immuno-allergic reaction, history of angioedema on ACE inhibitors or ARB2 inhibitors
* Symptomatic arterial hypotension or BPs \< 100 mHg
* Renal insufficiency (GFR \<30 mL/min/m²), hyperkalemia \> 5.4 mmol/l, severe hepatic insufficiency (Child-Pugh Class C)
* Pregnancy or breast-feeding
* Opposition to use of patient data
* Type 1 diabetes if on iSGLT2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06149806
Study Brief:
Protocol Section:
NCT06149806