Empagliflozin and dapagliflozin for improvement of outcome in patients with acute heart failure
Key facts
- Where
- Bielsko-Biala, Bydgoszcz, Chrzanów, Dąbrowa Górnicza, Gdansk, Gdynia, Kędzierzyn-Koźle, Lodz, Lublin, Mielec, Minsk Mazowiecki, Olsztyn, Opole, Sztum, Tychy és Warsaw, LengyelországSee the 19 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Lengyelország
- American Heart of Poland S.A.Bielsko-Biala, LengyelországNo longer taking part
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w BydgoszczyBydgoszcz, LengyelországNo longer taking part
- American Heart of Poland S.A.Chrzanów, LengyelországNo longer taking part
- American Heart of Poland S.A.Dąbrowa Górnicza, LengyelországNo longer taking part
- Uniwersyteckie Centrum KliniczneGdansk, LengyelországNo longer taking part
- Uniwersyteckie Centrum Medycyny Morskiej i TropikalnejGdynia, LengyelországNo longer taking part
- American Heart of Poland S.A.Kędzierzyn-Koźle, LengyelországNo longer taking part
- Instytut Centrum Zdrowia Matki PolkiLodz, LengyelországNo longer taking part
- Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego W Lodzi Centralny Szpital Weteranow SPZOZLodz, LengyelországNo longer taking part
- Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W LublinieLublin, LengyelországNo longer taking part
- Regionalne Centrum Krwiodawstwa I KrwiolecznictwaMielec, LengyelországNo longer taking part
- K2J2 Sp. z o.o.Minsk Mazowiecki, LengyelországNo longer taking part
- Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w OlsztynieOlsztyn, LengyelországNo longer taking part
- Wojewódzki Szpital Specjalistyczny w OlsztynieOlsztyn, LengyelországNo longer taking part
- Uniwersytecki Szpital Kliniczny w OpoluOpole, LengyelországNo longer taking part
- American Heart Of Poland S.A.Sztum, LengyelországNo longer taking part
- American Heart of Poland S.A.Tychy, LengyelországNo longer taking part
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i AdministracjiWarsaw, LengyelországNo longer taking part
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoWarsaw, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Of Warsaw
- Trial code
- EU 2024-518685-27-00
- Record updated
- 2024. december 2.
- Original description
The primary objective is to investigate and compare the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on primary and secondary clinical endpoints in patients hospitalized due to acute/decompensated HF regardless of ejection fraction (HFrEF, HFmEF, HFpEF) or diabetes status.Read full original descriptionShow less
EMpagliflozin and daPAgliflozin in patients hospiTalized for acute decompensated Heart failure (EMPATHY) – a phase III Trial
The primary objective is to investigate and compare the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on primary and secondary clinical endpoints in patients hospitalized due to acute/decompensated HF regardless of ejection fraction (HFrEF, HFmEF, HFpEF) or diabetes status.
Inclusion: Patients 18 years of age with the capacity to provide written informed consent; eGFR >20 ml/min/1,73m2; Currently hospitalized for a primary diagnosis of acute/decompensated HF (HFrEF, HFmrEF,HFpEF), including symptoms and signs of fluid overload regardless of ejection fraction or diabetes status; In patients with HFpEF the diagnosis has to be confirmed according to the current HFpEF definition (by non-invasive testing: evidence of structural or functional changes in the heart as evidenced on echocardiography or by invasive testing as LVEDP assessment or right heart catheterisation); Randomized no earlier than 24 hours and up to 10 days after initial presentation while still hospitalized; Stable as defined by: systolic blood pressure (SBP>100 mmHg for the preceding 6 hours); No intensification of IV diuretics within the last 6 hours; No use of IV vasodilators within the last 6 hours; No use of IV inotropes or levosimendan within the last 24 hours prior to randomization; Elevated NT-proBNP >600 pg/mL during the current hospitalization in patients with HFrEF and >300 pg/mL in patients with HFmrEF or HFpEF (or above 900 pg/ml if atrial fibrillation is present at admission independently from EF).
Exclusion: >1 episode of severe hypoglycaemia within the last 6 months under treatment with insulin or sulfonylurea; History of ketoacidosis; Acute symptomatic urinary tract infection or genital infection; Type 1 diabetes; SGLT-2 Inhibitor at baseline or known allergy to SGLT-2 Inhibitors; Current active cancer with less than 2 years of life expectancy; Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction; Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period; Pulmonary embolism, cerebrovascular accident as the primary trigger for the current hospitalization; Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant; Blood pH<7.32.