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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
This group of patients will receive the conventional treatment of heart failure according to the "2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure" and Sacubitril/Valsartan as an active comparator.
This group of patients will receive the conventional treatment of heart failure according to the "2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure" and Empagliflozin as an experimental drug.
National Institute of Cardiology Ignacio Chavez
Mexico City, Mexico
3D echocardiographic systemic ventricular end-diastolic volume index
Change of 8.2 ml or greater in systemic ventricular end-diastolic volume index measured by 3D echocardiogram.
Time frame: Twelve weeks
3D echocardiographic systemic ventricular end-systolic volume index
Change of 6.0 ml or greater in end-systolic volume index measured by 3D echocardiogram.
Time frame: Twelve weeks
Functional class
A clinically relevant change of greater than or equal to 5 points from baseline score in the functional class measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). This questionnaire evaluates 23 elements and is divided into 7 different domains. The score will interpreted as follows: 0-24 points: very poor to poor 25-49 points: poor to fair 50-74 points: fair to good 75-100 points: good to excellent
Time frame: Twelve weeks
Pulmonary congestion
Change in pulmonary B score measured by the quantification and characteristics of B-lines seen with pulmonary ultrasound assessing 8 regions total using the following scoring system: 0 points: less than 3 B-lines per zone 1 point: greater than or equal to 3 B-lines per zone
Time frame: Twelve weeks
6-minute walking test
Difference in meters walked in the 6-minute walking test.
Time frame: Twelve weeks
Echocardiographic ejection fraction from the systemic ventricle
A change in the percentage of ejection fraction from the systemic ventricle measured by echocardiogram.
Time frame: Twelve weeks
Echocardiographic longitudinal overall strain
A change in the percentage of longitudinal overall strain measured by echocardiogram at baseline and after treatment.
Time frame: Twelve weeks
NT-proBNP
Change in NT-proBNP values.
Time frame: Twelve weeks
Systemic venous congestion
Change in VExUS grading system measured by the diameter of the inferior vena cava in cm and Doppler pattern abnormalities on hepatic, portal and intra-renal veins using the following scoring system: No congestion (0): IVC less than 2 cm Mild (1): IVC greater than or equal to 2cm and any normal or mildly abnormal patterns Moderate (2): IVC greater than or equal to 2cm and ONE severely abnormal pattern Severe (3): IVC greater than or equal to 2 cm and more than or equal to TWO severely abnormal patterns
Time frame: Twelve weeks
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