Registry for patients with acute heart failure and reduced ejection fraction
a FOCUSed Prospective Registry on Acute Decompensation of Heart Failure With Reduced Ejection Fraction- The FOCUS-ADHF Registry
This study is collecting information from patients with acute heart failure and reduced ejection fraction to see how different treatments work in real-life settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | ASL Città di Torino Academic / other |
| Locations | 4 sites (Genk, Belgium and 3 other locations) |
| Trial ID | NCT06726109 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect real-life data on patients experiencing acute heart failure with reduced ejection fraction and dilated left ventricles. Patients will be enrolled consecutively at multiple centers and treated according to the latest European Society of Cardiology guidelines, with a focus on the use of intravenous vasodilators. The study will monitor treatment outcomes and the effectiveness of various therapeutic interventions as determined by the treating physicians. The goal is to better understand the management of these patients and improve therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates include patients admitted within 24 hours for acute decompensation of heart failure with specific echocardiographic and biomarker criteria.
Not a fit: Patients with acute heart failure who do not meet the inclusion criteria or have contraindications for the treatments being observed may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved treatment protocols for patients with acute heart failure, enhancing their quality of life and clinical outcomes.
How similar studies have performed: Other studies focusing on acute heart failure management have shown varying degrees of success, but this registry aims to provide more targeted insights into a specific patient population, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Genk, Belgium and 3 other locations
- division of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium. Hasselt University, Belgium. — Genk, Belgium, Belgium (Recruiting)
- Rivoli Hospital — Rivoli, Italy, Italy (Recruiting)
- San Giovanni Bosco Hospital — Turin, Italy, Italy (Recruiting)
- Santa Maria della Misericordia, Azienda sanitaria universitaria Friuli Centrale, — Udine, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Maurizio Bertaina, MD — Division of Cardiology, San Giovanni Bosco,ASL Città di Torino, Turin, Italy
- Study coordinator: Maurizio Bertaina, MD
- Email: maurizio.bertaina@gmail.com
- Phone: +393464300039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.