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

NCT05580510 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-11-02

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease
  • Heart Failure
  • Heart 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.

Sponsors & Collaborators

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Instituto Nacional de Cardiologia Ignacio Chavez

    lead OTHER

Principal Investigators

  • Edgar Garcia-Cruz, MD · National Institute of Cardiology Ignacio Chavez

  • Montserrat Villalobos-Pedroza, MD · National Institute of Cardiology Ignacio Chavez

  • Gian Jimenez-Rodriguez, MD · National Institute of Cardiology Ignacio Chávez

  • Carlos Guizar-Sanchez, MD · National Institute of Cardiology Ignacio Chávez

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2023-07-28
Completion
2024-03-29

Countries

  • Mexico

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580510 on ClinicalTrials.gov