National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Nov 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called Sacubitril/Valsartan in treating heart failure in adults with complex congenital heart disease, specifically those with conditions known as systemic right ventricle and single ventricle. Heart failure can be a serious issue for these patients, and the trial aims to gather more information on how this treatment works for them. Researchers will also look at another type of medication, known as iSGLT2, to see how it performs alongside Sacubitril/Valsartan.

To be eligible for this trial, participants must be at least 18 years old and have specific types of congenital heart disease with a weakened heart function (measured by a test called ejection fraction). They should also be experiencing moderate symptoms of heart failure and have been on optimal heart failure therapy for at least four weeks. Participants will receive regular follow-up examinations during the study, which will help researchers understand how well the treatments are working and if they are safe. It's important to note that certain health conditions, like severe kidney issues or pregnancy, may prevent someone from participating.

Gender

ALL

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