Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure

Summary

National, multicenter, randomized, double-blind, parallel-group, stratified by SGLT-2 inhibitor type, placebo-controlled trial, - a Phase III study. Primary objective of the study is to investigate the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on clinical endpoints in patients hospitalized with acute/decompensated HF.

Conditions

• Acute Decompensated Heart Failure

Interventions

DRUG

Empagliflozin 10 MG

once daily for 6 or 9 months

DRUG

Dapagliflozin 10 MG

once daily for 6 or 9 months

DRUG

Placebo

once daily for 3 months

Sponsors & Collaborators

• Medical University of Vienna

  collaborator OTHER

• Medical University of Graz

  collaborator OTHER

• University Clinical Center of the Medical University of Warsaw

  collaborator UNKNOWN

• Jerzy Popiełuszko Bielański Hospital in Warsaw

  collaborator UNKNOWN

• Regional Polyclinical Hospital in Kielce

  collaborator UNKNOWN

• University Clinical Hospital Military Medical Academy, Central Veterans Hospital in Łódź

  collaborator UNKNOWN

• Medical University of Gdansk

  collaborator OTHER

• Autonomous Public Specialist Western John Paul II Hospital in Grodzisk Mazowiecki

  collaborator UNKNOWN

• Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

  collaborator OTHER

• Poznan University of Medical Sciences

  collaborator OTHER

• John Paul II Hospital, Krakow

  collaborator OTHER

• Ludwik Rydygier Regional Polyclinical Hospital in Toruń

  collaborator UNKNOWN

• University Teaching Hospital in Białystok

  collaborator UNKNOWN

• Medical University of Silesia in Katowice

  collaborator UNKNOWN

• Medical University of Warsaw

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-15

Primary Completion

2024-09-30

Completion

2025-12-31

Countries

• Poland

Study Locations