LEIA-HF
Project data
Project financing: 20 582 000 PLN (including financing for UMED: 116 000,00 PLN), financed by the Medical Research Agency (ABM) - ABM/2019/1
Project description:
The study aims to test health effects of treating patients with severe heart failure (HF) with levosimendan, with the purpose of inhibiting disease progression, extending life expectancy after heart failure diagnosis and improving patients’ quality of life.
Heart failure (HF) is currently the biggest epidemiological and therapeutic problem in cardiology. The number of people in Poland with HF is estimated to be around 750 thousand. Patients with HF are at high risk of death and recurrent exacerbations, which require hospitalisation. The number of cases and hospitalisations due to HF has increased in recent years and it is estimated that this trend will continue. In 2018, the number of hospitalisations due to HF was approximately 240,000. The annual mortality rate after hospitalisation due to HF is 15%, and half of the patients die within five years.
The LEIA-HF study is designed to unequivocally answer the question (to confirm or deny the hypothesis) whether the administration of levosimendan infusions every 4 weeks (during one-day hospitalisations) for 12 months to patients with severe heart failure (HF), will significantly reduce the number of deaths and unplanned hospitalisations due to HF – assessed cumulatively (whichever occurs first).
The study was designed to additionally test whether, during the repeated levosimendan therapy: (1) the patients’ quality of life would improve, (2) the objective severity of HF (distance covered in the 6-minute test, NTproBNP levels, left ventricular ejection fraction and other echocardiographic parameters) would decrease, (3) the subjective symptoms of HF (NYHA class) would decrease, (4) whether levosimendan therapy will prevent premature death (by reducing 12- and 18-month mortality in the group of patients of working age) and whether it will prevent death in post-working age and, consequently, extend the life expectancy of patients with severe heart failure, (5) whether levosimendan therapy will increase the percentage of patients with complete recovery (percentage of patients with heart transplantation).
Beneficiary
Consortium composed of:
Medical University of Bialystok (Leader)
Partners:
- University of Opole
- Medical University of Lodz
- Poznan University of Medical Sciences
- Nicolaus Copernicus University of Toruń
- Institute of Cardiology in name of the Primate of the Millennium Stefan Cardinal Wyszynski
- Krakowski Szpital Specjalistyczny im. Jana Pawła II
- A.O.R.N. “Azienda Ospedaliera dei Colli”
Coordinating Principal Investigator
prof. Agnieszka M. Tycińska, MD, PhD
UMED Site Principal Investigator
prof. Jarosław Kasprzak, MD, PhD