The FOCUS-ADHF Registry

Launched by ASL CITTÀ DI TORINO · Dec 5, 2024

Keywords

ClinConnect Summary

The FOCUS-ADHF Registry is a clinical trial that aims to better understand how to treat patients who are admitted to the hospital with acute heart failure, specifically those who have a severely weakened heart muscle and certain heart conditions. This study is particularly focused on patients who have a dilated left ventricle and significant mitral regurgitation, which is when blood leaks back into the heart instead of flowing out properly. By tracking these patients and their treatments, the trial hopes to find out how effective different therapies are, especially the use of vasodilators (medications that help relax blood vessels) in improving their condition.

To participate in this trial, patients need to be admitted to the hospital within 24 hours of experiencing symptoms of heart failure that require treatment with intravenous diuretics (medications that help remove excess fluid). They also need to show specific signs on an echocardiogram, which is an ultrasound of the heart. The study will follow participants closely, monitoring their heart function and overall health for three months to see how well they respond to treatment. Importantly, this trial is not yet recruiting participants, but it is designed to help improve future care for patients with acute heart failure.

Gender

ALL

Eligibility criteria

• 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