A study to compare heart failure medicines in one combined pill with usual care.
Key facts
- Where
- Brno, Krnov, Olomouc, Ostrava és Prague 2, CsehországSee the 5 sites
- Phase
- 3. fázis
Where in Csehország
- Fakultni nemocnice BrnoBrno, CsehországToborzás még nem indult
- Sdruzene zdravotnicke zarizeni Krnov příspěvková organizaceKrnov, CsehországToborzás még nem indult
- University Hospital OlomoucOlomouc, CsehországToborzás még nem indult
- Fakultni nemocnice OstravaOstrava, CsehországToborzás még nem indult
- Vseobecna Fakultni Nemocnice V PrazePrague 2, CsehországToborzás még nem indult
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
- Institut De Recherches Internationales Servier IRIS
- Trial code
- EU 2026-526510-90-00
- Record updated
- 2026. november 11.
- Original description
To evaluate in participants admitted for acute HF the effect of treatment delivered as FDC (Fixed-dose combination) based strategy compared to usual care on HFE (Heart Failure Event) and cardiovascular deathRead full original descriptionShow less
A multinational, multicenter, prospective, randomized, open-label, event-driven trial with two parallel arms, to compare the efficacy and safety of Guideline-Directed Medical Therapy (GDMT) with the use of Fixed-Dose Combination (FDC) strategy versus usual care for the management of Heart Failure.
To evaluate in participants admitted for acute HF the effect of treatment delivered as FDC (Fixed-dose combination) based strategy compared to usual care on HFE (Heart Failure Event) and cardiovascular death
Inclusion: Adult men or women of any ethnic origin aged at least 18 years old to no more than 85 years old; Signed written informed consent to participate in the study; Hospitalization for the primary diagnosis of acute HF with dyspnea (at rest or exacerbated exertional) and at least two of the other signs/symptoms of decompensated HF (such as peripheral edema, rales on auscultation, pulmonary congestion on chest X-ray, elevated jugular venous pressure [JVP]) at admission; Elevated natriuretic peptide from admission to inclusion, N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) ≥ 1600 pg/mL or B-Type Natriuretic Peptide (BNP) ≥ 400 pg/mL. Patients with atrial fibrillation: NT-proBNP ≥ 2400 pg/mL or BNP ≥ 600 pg/mL; Hemodynamically stable* participants included between 48 hours and 10 days after admission. *This term excludes any vasoactive intravenous vasopressors, inotropes, vasodilators, and IV diuretics within the last 24h before inclusion; No contraindications to SGLT2i (Sodium-GLucose co-Transporter-2 inhibitor), BB (Beta-Blocker) and MRA (Mineralocorticoid Receptor Antagonist) at inclusion; Systolic blood pressure (SBP) ≥ 100 mmHg and/or heart rate (HR) ≥ 60 bpm at inclusion; Left ventricular ejection fraction (LVEF) < 50% documented on the last assessment within the last 12 months before inclusion.
Exclusion: Type 1 diabetes mellitus; Serum potassium (K+) < 3.2 mmol/L or > 5.0 mmol/L at inclusion; Serum sodium (Na+) <130 mmol/L or >150 mmol/L at inclusion; Renal disease with estimated glomerular filtration rate eGFR ≤ 30 mL/min/1.73 m2 (as estimated by the simplified Modification of Diet in Renal Disease [MDRD] formula at inclusion, or history of dialysis.