Registry for patients with acute heart failure and reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.