EMPATHY

Project title: EMpagliflozin and daPAgliflozin in patients hospiTalized for acute decompensated Heart failure (EMPATHY trial)

Project data

Project financing: 30 084 379,80 PLN (including financing for UMED: 1 024 068 PLN), financed by the Medical Research Agency (ABM) - ABM/2019/1

Project description:

The project includes a clinical trial which aims to test the effect of different SGLT-2 inhibitors (empagliflozin, canagliflozin and dapagliflozin) on clinical outcomes in acute heart failure (AHF). This study is highly significant because the data to date shows that SGLT-2 inhibitors in patients with type 2 diabetes reduce the risk of hospitalisation for heart failure and cardiovascular mortality, in addition, they reduced the risk of heart failure by 30% and resulted in a significant 35% relative risk reduction in hospitalisation for HF (heart failure), and SGLT-2 inhibitors reduced the primary composite endpoint including cardiovascular death and non-fatal myocardial infarction and stroke.

In contrast, no study has compared the effect of different SGLT-2 inhibitors on outcomes in AHF.

The project aims to assess:

  • the effect of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on primary and secondary clinical endpoints in patients with acute/uncompensated heart failure (AHF);
  • the effect of SGLT-2 inhibitors on cardiac function;
  • the effect of SGLT-2 inhibitors on biomarkers and circulating micro RNAs (miRNAs) and microbiome metabolites
  • and propose a risk prediction scale to closely monitor the course of AHF and its treatment with SGLT-2 inhibitors based on selected miRNAs and biomarkers related to molecular pathways associated with disease progression.

Beneficiary

Consortium composed of:

  • Medical University of Warsaw (WUM) – Leader

Partners:

  • University Clinical Centre of Medical University of Warsaw
  • Rev. Jerzy Popiełuszko Bielanski Hospital
  • Medical University of Lodz
  • Medical University of Gdańsk
  • St John Paul II Independent Public Specialist Western Hospital
  • Nicolaus Copernicus University of Toruń
  • Hospital of Lord’s Transfiguration of Poznan University Of Medical Sciences (SKPP)
  • Clinic of Interventional Cardiology, Institute of Cardiology, Jagiellonian University, Collegium Medicum, John Paul II Specialist Hospital in Krakow
  • Medical University of Piastów Śląskich in Wrocław
  • Medical University of Bialystok
  • Medical University of Silesia in Katowice
  • Medical University of Vienna
  • Medical University of Graz

Coordinating Principal Investigator

prof. Jolanta Siller-Matula, MD, PhD

UMED Site Principal Investigator

prof. Robert Irzmański, MD, PhD

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