" Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "

"An Open-label Clinical Trial to Evaluate the Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan in Adult Patients With Chronic Heart Failure With Reduced Ejection Fraction Associated With Congenital Heart Disease"

The treatment of adult patients with congenital heart disease (ACHD) and heart failure (HF) represents a great challenge since, to date, there is no standardized guideline for this specific population. Although new treatments for HF have been proposed, such as Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and neprilisin and angiotensin receptor inhibitors, the benefit of these drugs in patients with HF associated with congenital heart disease in adults has not yet been demonstrated. For this reason, this study pretends to evaluate the efficacy of empagliflozin and sacubitril/valsartan in this population.

A 12-week randomized, open label, active-controlled trial to explore the effects of once-daily empagliflozin 10 mg and/or sacutril/valsartan 49 mg/51 mg in the reduction of systemic ventricular volumes (end-diastolic and end-systolic) in adult patients with HF associated with congenital heart disease.

Inclusion Criteria:

• NYHA functional class II-IV
• Diagnosis of CHD: repaired, palliated or without previous treatment
• Systemic ventricular ejection fraction <40%
• Without unplanned hospital admissions within 3 months prior to randomization
• The participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

• Pregnant and postpartum women
• Breastfeeding women during the study
• History of drug allergy to any SGLT-2 inhibitor and/or sacubitril/valsartan
• Previous administration of a drug regimen including an SGLT-2 inhibitor and/or sacubitril/valsartan
• Intellectual or physical disability that impedes the subject to perform the 6 minute walk-test
• Patients with any contraindication to SGLT-2 inhibitor and/or sacubitril/valsartan
• Medical history of myocardial infarction, cardiac surgery or fulminant myocarditis within the last three months
• Medical history of type 1 diabetes mellitus
• Medical history of hypertensive crisis in the previous 6-months
• Medical history of cardiogenic shock or heart failure decompensation in the previous 6-months
• Medical history of heart transplantation