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

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

February 6, 2023

Primary Completion Date

July 28, 2023

Study Completion Date

March 29, 2024

Conditions
Congenital Heart DiseaseHeart FailureHeart Failure With Reduced Ejection Fraction
Interventions
DRUG

Sacubitril 49 MG / Valsartan 51 MG [Entresto] BID

"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."

DRUG

Empagliflozin 10 MG OD

"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."

Trial Locations (1)

14080

National Institute of Cardiology Ignacio Chavez, Mexico City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Boehringer Ingelheim

INDUSTRY

lead

Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

NCT05580510 - " Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD " | Biotech Hunter | Biotech Hunter