The FOCUS-ADHF Registry (FOCUS-ADHF)

May 2, 2025 updated by: Maurizio Bertaina, ASL Città di Torino

a FOCUSed Prospective Registry on Acute Decompensation of Heart Failure With Reduced Ejection Fraction- The FOCUS-ADHF Registry

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 filling pressure. Patients with such characteristics show higher myocardial wall tension and are particularly vulnerable to afterload increases, positioning them as optimal candidates for vasodilator therapy during acute decompensation. Little evidence is available from real world cohort study on the benefit of vasodilators in this group of patients. Many of these studies used pre-defined protocol and invasive hemodynamic monitoring. On the contrary the use of echocardiographic evaluation to phenotype, infer hemodynamic parameters and assess treatment effect has become the most common adopted technique in real life.

The present prospective registry aims to investigate acute treatment management and outcomes in a focused population of patients admitted for an acute decompensation of heart failure (ADHF) with severely reduced ejection fraction and dilated left ventricle or significant functional mitral regurgitation.

Inclusion Criteria:

  • Patients within 24h since admission for an ADHF 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.

      • Admission echocardiography with evidence of a dilated left ventricle and/or at least moderate functional mitral regurgitation (FMR), reduced ejection fraction (<40%), increased LV (II/III degree diastolic dysfunction) and pulmonary pressure (sPAP ≥ 40 mmHg or MPAP ≥ 20 mmHg).

      Exclusion Criteria:

      - Cardiogenic shock at admission warranting immediate MCS / inotropic support, severe renal or hepatic impairment, recent myocardial infarction, and other terminal illnesses.

      • Use of vasopressors/inotropes or mechanical support at admission. Methods Patients will receive treatments according to their physician's discretion based on ESC guidelines. Serial evaluations of heart function will be conducted using echocardiography and lung ultrasound (LUS) at multiple time points as well as hemodynamic data, laboratory and HF medications' prescription and dosages Primary endpoint

        • 3 months incidence of need of Heart Replacement Therapies (LVAD or heart transplantation) and/or heart failure re-hospitalization and/or all-cause death.

      Secondary endpoints • In hospital and 3 months All-cause death

      • All cause and HF related hospitalizations within 3 months

      • Heart replacement therapies (LVAD or heart transplantation) within 3 months.

      • In hospital Worsening Heart Failure (WHF)

      • Need of renal replacement therapy (RRT) within 3 months

      • In-hospital length of stay (days), NT-proBNP variations, GDMT and diuretics prescription and dosages up to three months;

      Objectives:

    1. To describe the acute therapeutic management and discharge prescriptions for heart failure medications, including doses, in a selected population with ADHF.
    2. To evaluate clinical outcomes and NT-proBNP variation in relation to initial intravenous medications, particularly comparing the use versus non-use of vasodilators.
    3. To identify the incidence and timing of a significant therapeutic response through serial evaluations of LUS and echo-derived parameters, and to examine their association with the initial intravenous medications prescribed.
    4. To investigate the association between the criteria for therapeutic response and clinical outcomes in both short- and medium-term follow-up, with a focus on the relationship to the initially administered therapy.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a real-life, observational, prospective multicenter registry. Patients fulfilling inclusion and exclusion criteria will be consecutively enrolled in enrolling center.

Enrolled patients will be treated at each treating physician's discretion referring to the general recommendation of the last ESC guidelines on management of acute heart failure as well as local practice. General guidelines for vasodilators use will be shared among enrolling centers to increase uniformity of treatment in case of prescription of this strategy.

-After achievement of adequate decongestion, iv vasodilators infusion (if used) will be weaned and HF medications introduction/titration up to guidelines recommended doses.

Other therapeutic interventions: will be left to treating physician discretion aiming to decongest the patient.

Starting inotropes, vasopressors, mechanical cardiac support device (MCS) and use of non-invasive and/or invasive ventilation as well as continuous renal replacement therapies (CRRT) will be left to the treating physicians' discretion according to clinical course.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Genk, Belgium
        • Recruiting
        • division of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium. Hasselt University, Belgium.
        • Principal Investigator:
          • Wilfred Mullens, MD, Prof.
  • Italy
      • Rivoli, Italy
        • Recruiting
        • Rivoli Hospital
        • Contact:
        • Principal Investigator:
          • Alessandro Galluzzo, MD
      • Turin, Italy, 10154
        • Recruiting
        • San Giovanni Bosco Hospital
        • Contact:
        • Principal Investigator:
          • Maurizio Bertaina, MD
      • Udine, Italy
        • Recruiting
        • Santa Maria della Misericordia, Azienda sanitaria universitaria Friuli Centrale,
        • Contact:
          • Davide Stolfo, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All-comers patients admitted for an ADHF with a severely reduced ejection fraction, a dilated left ventricle or significant functional mitral regurgitation (FMR) and increased left ventricle filling and pulmonary pressures as estimated by echocardiographic evaluation at admission.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
vasodilator treated
patients treated with vasodilator therapy after admission for an ADHF episode
Not vasodilator treated
Patients not treated with vasodilator therapy after admission for an ADHF episode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of need of Heart Replacement Therapies (LVAD or heart transplantation) and/or heart failure re-hospitalization and/or all-cause death.
Time Frame: from enrollment up to 3 months
from enrollment up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of all-cause mortality
Time Frame: from enrollment up to 3 months
from enrollment up to 3 months
incidence of HF related hospitalizations
Time Frame: from enrollment up to 3 months
from enrollment up to 3 months
incidence of all-cause hospitalization
Time Frame: from enrollment up to 3 months
from enrollment up to 3 months
incidence of patients needing heart replacement therapies (LVAD or heart transplantation)
Time Frame: from enrollment up to 3 months
Heart transplantation or LVAD implantation
from enrollment up to 3 months
incidence of In hospital Worsening Heart Failure (WHF)
Time Frame: from date of enrollment until the date of first worsening heart failure event or the date of death from any cause or the date of hospital discharge, whichever came first, assessed up to 3 months
need for therapeutic intensification for inadequate clinical response
from date of enrollment until the date of first worsening heart failure event or the date of death from any cause or the date of hospital discharge, whichever came first, assessed up to 3 months
incidence of patients needing renal replacement therapy (RRT)
Time Frame: from enrollment up to 3 months
need for use of renal replacement therapy
from enrollment up to 3 months
rate of GDMT and diuretics prescription and dosages
Time Frame: from admission up to 3 months follow-up
prescription of 4 hf pillars, Vericiguat, diuretics and doses
from admission up to 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASL Città di Torino

Collaborators

Ziekenhuis Oost-Limburg
Hospital of Rivoli

Investigators

  • Principal Investigator: Maurizio Bertaina, MD, Division of Cardiology, San Giovanni Bosco,ASL Città di Torino, Turin, Italy
  • Principal Investigator: Wilfred Mullens, MD,Prof., Division of Cardiology,Ziekenhuis Oost-Limburg, Genk, Belgium. Hasselt University, Belgium.
  • Principal Investigator: Alessandro Galluzzo, MD, Division of cardiology, Rivoli Hospital, Rivoli, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2025

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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