The FOCUS-ADHF Registry

Summary

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:

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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.

Conditions

• Acute Heart Failure With Reduced Ejection Fraction
• Decompensation; Heart, Congestive
• Regurgitation, Mitral

Sponsors & Collaborators

• Hospital of Rivoli

  collaborator UNKNOWN

• Ziekenhuis Oost-Limburg

  collaborator OTHER

• ASL Città di Torino

  lead OTHER

Principal Investigators

• Maurizio Bertaina, MD · Division of Cardiology, San Giovanni Bosco,ASL Città di Torino, Turin, Italy

• Wilfred Mullens, MD,Prof. · Division of Cardiology,Ziekenhuis Oost-Limburg, Genk, Belgium. Hasselt University, Belgium.

• Alessandro Galluzzo, MD · Division of cardiology, Rivoli Hospital, Rivoli, Italy

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-27

Primary Completion

2030-04-30

Completion

2030-08-31

Countries

• Belgium
• Italy

Study Locations