Registry of adults with heart failure and complex congenital heart disease treated with Sacubitril/Valsartan
National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan
This study is testing if a heart medication called Sacubitril/Valsartan can help adults with heart failure caused by complex congenital heart disease feel better and improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (La Tronche) |
| Trial ID | NCT06149806 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and tolerability of Sacubitril/Valsartan in adults suffering from heart failure due to complex congenital heart disease, specifically those with systemic right ventricle and single ventricle conditions. The study will involve a multicenter approach, collecting data from various locations to better understand the treatment's impact on this unique patient population. Participants will be monitored for their heart function and overall health while receiving optimal heart failure therapy. The findings could help establish more tailored management strategies for these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with congenital heart disease characterized by systemic right ventricle or single ventricle and a systemic ventricular ejection fraction of 40% or less.
Not a fit: Patients with other types of congenital heart disease or those unable to perform necessary cardiopulmonary exercise tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for adults with complex congenital heart disease and heart failure.
How similar studies have performed: While there is limited published data on the use of Sacubitril/Valsartan in this specific population, other studies have shown its efficacy in treating heart failure in adults with acquired left ventricular dysfunction.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Tronche
- Chu Grenoble Alpes — La Tronche, France (Recruiting)
Study contacts
- Study coordinator: Claire Massardier, MD
- Email: cmassardier@chu-grenoble.fr
- Phone: 0476768888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.