Heart Failure Clinical Trial
Official title:
"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.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | March 29, 2024 |
Est. primary completion date | July 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | National Institute of Cardiology Ignacio Chavez | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cardiologia Ignacio Chavez | Boehringer Ingelheim laboratory |
Mexico,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Twelve weeks | |
Primary | 3D echocardiographic systemic ventricular end-systolic volume index | Change of 6.0 ml or greater in end-systolic volume index measured by 3D echocardiogram. | Twelve weeks | |
Secondary | 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 |
Twelve weeks | |
Secondary | 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 |
Twelve weeks | |
Secondary | 6-minute walking test | Difference in meters walked in the 6-minute walking test. | Twelve weeks | |
Secondary | Echocardiographic ejection fraction from the systemic ventricle | A change in the percentage of ejection fraction from the systemic ventricle measured by echocardiogram. | Twelve weeks | |
Secondary | Echocardiographic longitudinal overall strain | A change in the percentage of longitudinal overall strain measured by echocardiogram at baseline and after treatment. | Twelve weeks | |
Secondary | NT-proBNP | Change in NT-proBNP values. | Twelve weeks | |
Secondary | 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 |
Twelve weeks |
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