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Acute Heart Failure With Reduced Ejection FractionFOCUS-ADHFNCT06726109

The FOCUS-ADHF Registry

An observational study of Acute Heart Failure With Reduced Ejection Fraction and Decompensation; Heart, Congestive, run by ASL Città di Torino at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any age
How many people
600 participants
Where
4 sitesin 2 countries
Study dates
27 Apr 2025to Aug 2030
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • Patients within 24h since admission for an acute decompensation of heart failure (ADHF)* (both acute on chronic and de novo) defined as
  • signs and symptoms of volume overload with necessity of iv diuretic treatment.
  • 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:
  • 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).
  • Reduced ejection fraction (<40%)
  • 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).

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Maurizio Bertaina, MD contact

+393464300039

maurizio.bertaina@gmail.com

4 sites in 2 countries

Italy3 sites, 3 recruiting

  • Rivoli Hospital

    Rivoli, Italy

    Alessandro Galluzzo, MD, alegallu@yahoo.it

    Alessandro Galluzzo, MD

    Recruiting

  • San Giovanni Bosco Hospital

    Turin, Italy, 10154

    Maurizio Bertaina, MD, +393464300039, maurizio.bertaina@gmail.com

    Maurizio Bertaina, MD

    Recruiting

  • Santa Maria della Misericordia, Azienda sanitaria universitaria Friuli Centrale,

    Udine, Italy

    Davide Stolfo, MD,PhD

    Recruiting

Other trials in Italy

Belgium1 site, 1 recruiting

  • division of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium. Hasselt University, Belgium.

    Genk, Belgium

    Wilfred Mullens, MD, Prof.

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Read more

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.
Read the 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.

Keywords
Acute Heart Failure (AHF), Acute Decompensated Heart Failure (ADHF), Vasodilators, Dilated left ventricle, reduced ejection fraction (rEF), functional mitral regurgitation (FMR), increased filling pressure, increased pulmonary artery pressure, nitroprusside, sodium nitroprusside, Isosorbide Dinitrate, nitroglycerine
Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06726109
Study groupRoleWhat they receive
vasodilator treatedpatients treated with vasodilator therapy after admission for an ADHF episode
Not vasodilator treatedPatients not treated with vasodilator therapy after admission for an ADHF episode

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: from enrollment up to 3 months

Secondary outcomes (7)

  1. incidence of all-cause mortality

    Measured: from enrollment up to 3 months

  2. incidence of HF related hospitalizations

    Measured: from enrollment up to 3 months

  3. incidence of all-cause hospitalization

    Measured: from enrollment up to 3 months

  4. incidence of patients needing heart replacement therapies (LVAD or heart transplantation)

    Heart transplantation or LVAD implantation

    Measured: from enrollment up to 3 months

  5. incidence of In hospital Worsening Heart Failure (WHF)

    need for therapeutic intensification for inadequate clinical response

    Measured: 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

  6. incidence of patients needing renal replacement therapy (RRT)

    need for use of renal replacement therapy

    Measured: from enrollment up to 3 months

  7. rate of GDMT and diuretics prescription and dosages

    prescription of 4 hf pillars, Vericiguat, diuretics and doses

    Measured: from admission up to 3 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start27 Apr 2025
  3. Primary completionApr 2030 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06726109
Sponsor's protocol ID
01
Acronym
FOCUS-ADHF
Status last verified
May 2025
First submitted
20 Nov 2024
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Platz E, Jhund PS, Girerd N, Pivetta E, McMurray JJV, Peacock WF, Masip J, Martin-Sanchez FJ, Miro O, Price S, Cullen L, Maisel AS, Vrints C, Cowie MR, DiSomma S, Bueno H, Mebazaa A, Gualandro DM, Tavares M, Metra M, Coats AJS, Ruschitzka F, Seferovic PM, Mueller C; Study Group on Acute Heart Failure of the Acute Cardiovascular Care Association and the Heart Failure Association of the European Society of Cardiology. Expert consensus document: Reporting checklist for quantification of pulmonary congestion by lung ultrasound in heart failure. Eur J Heart Fail. 2019 Jul;21(7):844-851. doi: 10.1002/ejhf.1499. Epub 2019 Jun 19.

    PubMed 31218825

  • Metra M, Adamo M, Tomasoni D, Mebazaa A, Bayes-Genis A, Abdelhamid M, Adamopoulos S, Anker SD, Bauersachs J, Belenkov Y, Bohm M, Gal TB, Butler J, Cohen-Solal A, Filippatos G, Gustafsson F, Hill L, Jaarsma T, Jankowska EA, Lainscak M, Lopatin Y, Lund LH, McDonagh T, Milicic D, Moura B, Mullens W, Piepoli M, Polovina M, Ponikowski P, Rakisheva A, Ristic A, Savarese G, Seferovic P, Sharma R, Thum T, Tocchetti CG, Van Linthout S, Vitale C, Von Haehling S, Volterrani M, Coats AJS, Chioncel O, Rosano G. Pre-discharge and early post-discharge management of patients hospitalized for acute heart failure: A scientific statement by the Heart Failure Association of the ESC. Eur J Heart Fail. 2023 Jul;25(7):1115-1131. doi: 10.1002/ejhf.2888. Epub 2023 Jul 13.

    PubMed 37448210

  • Gentile F, Buoncristiani F, Sciarrone P, Bazan L, Panichella G, Gasparini S, Chubuchny V, Taddei C, Poggianti E, Fabiani I, Petersen C, Lancellotti P, Passino C, Emdin M, Giannoni A. Left ventricular outflow tract velocity-time integral improves outcome prediction in patients with secondary mitral regurgitation. Int J Cardiol. 2023 Dec 1;392:131272. doi: 10.1016/j.ijcard.2023.131272. Epub 2023 Aug 19.

    PubMed 37604287

  • Frea S, Gravinese C, Boretto P, De Lio G, Bocchino PP, Angelini F, Cingolani M, Gallone G, Montefusco A, Valente E, Pidello S, Raineri C, De Ferrari GM. Comprehensive non-invasive haemodynamic assessment in acute decompensated heart failure-related cardiogenic shock: a step towards echodynamics. Eur Heart J Acute Cardiovasc Care. 2024 Sep 25;13(9):646-655. doi: 10.1093/ehjacc/zuae087.

    PubMed 39012797

  • Bertaina M, Galluzzo A, Rossello X, Sbarra P, Petitti E, Prever SB, Boccuzzi G, D'Ascenzo F, Frea S, Pidello S, Morici N, Sacco A, Oliva F, Valente S, De Ferrari GM, Ugo F, Rametta F, Attisani M, Zanini P, Noussan P, Iannaccone M. Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies. J Crit Care. 2022 Jun;69:154024. doi: 10.1016/j.jcrc.2022.154024. Epub 2022 Mar 25.

    PubMed 35344825

  • Binanay C, Califf RM, Hasselblad V, O'Connor CM, Shah MR, Sopko G, Stevenson LW, Francis GS, Leier CV, Miller LW; ESCAPE Investigators and ESCAPE Study Coordinators. Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial. JAMA. 2005 Oct 5;294(13):1625-33. doi: 10.1001/jama.294.13.1625.

    PubMed 16204662

  • Verbrugge FH, Dupont M, Finucan M, Gabi A, Hawwa N, Mullens W, Taylor DO, Young JB, Starling RC, Tang WH. Response and tolerance to oral vasodilator up-titration after intravenous vasodilator therapy in advanced decompensated heart failure. Eur J Heart Fail. 2015 Sep;17(9):956-63. doi: 10.1002/ejhf.324. Epub 2015 Jul 24.

    PubMed 26213182

  • Mullens W, Abrahams Z, Francis GS, Skouri HN, Starling RC, Young JB, Taylor DO, Tang WH. Sodium nitroprusside for advanced low-output heart failure. J Am Coll Cardiol. 2008 Jul 15;52(3):200-7. doi: 10.1016/j.jacc.2008.02.083.

    PubMed 18617068

  • Garatti L, Frea S, Bocchino PP, Angelini F, Cingolani M, Sacco A, Rondinara GM, Bagnardi V, Sala IM, Kapur NK, Colombo PC, De Ferrari GM, Morici N. Sodium nitroprusside in acute heart failure: A multicenter historic cohort study. Int J Cardiol. 2022 Dec 15;369:37-44. doi: 10.1016/j.ijcard.2022.08.009. Epub 2022 Aug 6.

    PubMed 35944767

  • Freund Y, Cachanado M, Delannoy Q, Laribi S, Yordanov Y, Gorlicki J, Chouihed T, Feral-Pierssens AL, Truchot J, Desmettre T, Occelli C, Bobbia X, Khellaf M, Ganansia O, Bokobza J, Balen F, Beaune S, Bloom B, Simon T, Mebazaa A. Effect of an Emergency Department Care Bundle on 30-Day Hospital Discharge and Survival Among Elderly Patients With Acute Heart Failure: The ELISABETH Randomized Clinical Trial. JAMA. 2020 Nov 17;324(19):1948-1956. doi: 10.1001/jama.2020.19378.

    PubMed 33201202

  • Metra M, Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Voors AA, Adams KF, Anker SD, Arias-Mendoza A, Avendaño P, Bacal F, Böhm M, Bortman G, Cleland JGF, Cohen-Solal A, Crespo-Leiro MG, Dorobantu M, Echeverría LE, Ferrari R, Goland S, Goncalvesová E, Goudev A, Køber L, Lema-Osores J, Levy PD, McDonald K, et al. Effects of Serelaxin in Patients with Acute Heart Failure. N Engl J Med N Engl J Med; 2019;381:716-726.

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, Meer P Van Der, Sisakian HS, Isayev E, Kurlianskaya A, Mullens W, Tokmakova M, Agathangelou P, Melenovsky V, Wiggers H, Hassanein M, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 2016;37:2129-2200m.

  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J Oxford Academic; 2021;42:3599-3726.

  • Kozhuharov N, Goudev A, Flores D, Maeder MT, Walter J, Shrestha S, Gualandro DM, de Oliveira Junior MT, Sabti Z, Muller B, Noveanu M, Socrates T, Ziller R, Bayes-Genis A, Sionis A, Simon P, Michou E, Gujer S, Gori T, Wenzel P, Pfister O, Conen D, Kapos I, Kobza R, Rickli H, Breidthardt T, Munzel T, Erne P, Mueller C; GALACTIC Investigators; Mueller C, Erne P, Muller B, Rickli H, Maeder M, Tavares de Oliveira M Jr, Munzel T, Bayes-Genis A, Sionis A, Goudev A, Dimov B, Hartwiger S, Arenja N, Glatz B, Herr N, Isenrich R, Mosimann T, Twerenbold R, Boeddinghaus J, Nestelberger T, Puelacher C, Freese M, Vogele J, Meissner K, Martin J, Strebel I, Wussler D, Schumacher C, Osswald S, Vogt F, Hilti J, Barata S, Schneider D, Schwarz J, Fitze B, Hartwiger S, Arenja N, Glatz B, Herr N, Isenrich R, Mosimann T, Twerenbold R, Boeddinghaus J, Nestelberger T, Puelacher C, Freese M, Vogele J, Meissner K, Martin J, Strebel I, Wussler D, Schumacher C, Osswald S, Vogt F, Hilti J, Barata S, Schneider D, Schwarz J, Fitze B, Arenja N, Rentsch K, Bossa A, Jallad S, Soeiro A, Georgiev D, Jansen T, Gebel G, Bossard M, Christ M. Effect of a Strategy of Comprehensive Vasodilation vs Usual Care on Mortality and Heart Failure Rehospitalization Among Patients With Acute Heart Failure: The GALACTIC Randomized Clinical Trial. JAMA. 2019 Dec 17;322(23):2292-2302. doi: 10.1001/jama.2019.18598.

    PubMed 31846016

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Heart Failure With Reduced Ejection Fraction and Decompensation; Heart, Congestive, run by ASL Città di Torino at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maurizio Bertaina, MD (+393464300039, maurizio.bertaina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06726109, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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