Status:
UNKNOWN
National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Complex Congenital Heart Disease
Eligibility:
All Genders
18+ years
Brief Summary
Heart failure in adults with congenital heart disease is a major cause of morbidity and mortality. Patients with systemic right ventricle (SRV) and single ventricle (SV) are particularly at risk1, 2, ...
Eligibility Criteria
Inclusion
- \- 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
- \- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06149806
Start Date
July 1 2021
End Date
December 1 2025
Last Update
November 29 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu Grenoble Alpes
La Tronche, France, 38700