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The FOCUS-ADHF Registry

Recruitingn/aAges any - anyAllASL Città di Torino
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In plain words

What the trial is, and whether it could suit you

Acute heart failure (AHF) represents a significant clinical and economic burden due to its impact on patients' quality of life, poor prognosis, and high healthcare costs. Despite advancements in treatment, the optimal therapeutic management of these patients, particularly those with severely reduced ejection fraction and dilated left ventricles, remains uncertain. The last European Society of Cardiology (ESC) guidelines gave a weak recommendation for using intravenous (IV) vasodilators in patients with adequate systolic blood pressure. This is derived from heterogeneous randomized controlled trials (RCTs) enrolling all-comers heart failure patients. Those studies did not specifically target conditions that from a pathophysiological perspective might derive potential positive response from vasodilators like left ventricle dilatation, significant mitral regurgitation and/or increased filli

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Patients within 24h since admission for an acute decompensation of heart failure (ADHF)\* (both acute on chronic and de novo) defined as 1. signs and symptoms of volume overload with necessity of iv diuretic treatment. 2. and NT-proBNP (N-terminal pro-B-type natriuretic peptide) \>1500 pg/mL or a B-type natriuretic peptide level of \>500 ng/mL. AND ALL THE FOLLOWING echo entry criteria at admission: 1. A dilated left ventricle (defined as a indexed LVEDD ≥ 31 mm/sm and ≥ 32 mm/sm or a indexed LVEDVol ≥ 75 ml/sm and ≥ 62 ml/sm in men and women respectively) AND/OR at least moderate functional mitral regurgitation (FMR). 2. Reduced ejection fraction (\<40%) 3. Increased LV filling pressure (defined as II°-III° Diastolic dysfunction) AND increased pulmonary artery pressure (i.e. echo estimated systolic pulmonary artery pressure \[sPAP\] ≥ 40 mmhg and/or echo estimated mean pulmonary artery pressure \[mPAP\] ≥ 20 mmHg). Exclusion Criteria: * Patients presenting in Cardiogenic shock defined as hypotension (SBP \< 90mmHg or MAP ≤ 55) AND hypoperfusion (defined as arterial lactates \> 4 mmol/L) * Estimated GFR \<=20 ml/min/1.73 m2 or in chronic renal replacement therapies. * End-stage hepatic impairment * Use of temporary mechanical support at the moment of study inclusion or planned to use it within hours (IABP; Impella, VA ECMO) * Ongoing treatment with vasopressors/inotropes at the moment of randomization or administration of Levosimendan within 30 days before randomization. Patients admitted for a planned cycle of Levosimendan infusion will be excluded by the present study as well. * AHF secondary to recent onset tachy-arrhythmias * ST tract elevated myocardial infarction (STEMI) \< 30 days, myocarditis \<30 days, AHF due to severe primary valve disease or clinical suspicion of an acute mechanical cause of AHF * restrictive cardiomyopathy, constrictive pericarditis, hypertrophic obstructive cardiomyopathy, tako-tsubo syndrome * Infective endocarditis, concomitant active septic disease as predominant cause of decompensation or admission TC\>38°c. * LVAD carriers or Heart transplant recipients * Terminal illness other than heart failure with an expected survival \<180 days
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What it tests

  • Not listed
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Where

4 sites
division of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium. Hasselt University, Belgium.
Genk, Belgium
Rivoli Hospital
Rivoli, Italy
San Giovanni Bosco Hospital
Turin, Italy
Santa Maria della Misericordia, Azienda sanitaria universitaria Friuli Centrale,
Udine, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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