Clinical trial NCT05580510: " Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "
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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Congenital Heart Disease
Heart Failure
Heart Failure With Reduced Ejection Fraction
Keywords: Adult congenital heart disease
Heart Failure with Reduced Ejection Fraction
Empagliflozin
Sacubitril-valsartan
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2022-10-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label randomized clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 3D echocardiographic systemic ventricular end-diastolic volume index
timeFrame: Twelve weeks
measure: 3D echocardiographic systemic ventricular end-systolic volume index
timeFrame: Twelve weeks
Secondary outcomes:
measure: Functional class
timeFrame: Twelve weeks
measure: Pulmonary congestion
timeFrame: Twelve weeks
measure: 6-minute walking test
timeFrame: Twelve weeks
measure: Echocardiographic ejection fraction from the systemic ventricle
timeFrame: Twelve weeks
measure: Echocardiographic longitudinal overall strain
timeFrame: Twelve weeks
measure: NT-proBNP
timeFrame: Twelve weeks
measure: Systemic venous congestion
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Cardiology Ignacio Chavez
Study officials:
affiliation: National Institute of Cardiology Ignacio Chavez
name: Edgar Garcia-Cruz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology Ignacio Chavez
name: Montserrat Villalobos-Pedroza, MD
role: STUDY_CHAIR
affiliation: National Institute of Cardiology Ignacio Chávez
name: Gian Jimenez-Rodriguez, MD
role: STUDY_CHAIR
affiliation: National Institute of Cardiology Ignacio Chávez
name: Carlos Guizar-Sanchez, MD
role: STUDY_DIRECTOR
References:
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