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Heart Failuread-HUBNCT07560982

Evaluating Adherence to Guideline-Directed Medical Therapy in Patients With Advanced Heart Failure

An observational study of Heart Failure, run by Università Vita-Salute San Raffaele at 2 sites in Italy.

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

A Prospective Observational, Multi-Center, Real-World Pharmacological Study Evaluating Adherence to Guideline-Directed Medical Therapy Using the Four-Pillar Strategy in Patients with Advanced Heart Failure Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Heart Failure
What is being tested?
GDMT and Quality of life questionnaire
How many people
300 participants
Where
2 sitesItaly
Study dates
8 May 2026to 1 Jul 2036
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with advanced heart failure, the proportion of patients receiving GDMT will be assessed.

Who may be able to join

  • Age > 18 and < 75 years
  • Heart failure with left ventricular ejection fraction ≤ 35%
  • Persistent symptoms of heart failure, New York Heart Association class III or IV
  • Requirement for high-dose diuretic therapy, specifically Furosemide > 50 mg/day orally as per routine clinical practice
  • At least one of the following additional indicators of severity or refractoriness:
  • need for progressive escalation of diuretics,
Show all 9Show fewer
  • intolerance to optimized medical therapy,
  • persistence of symptoms despite advanced treatments such as (but not limited to) cardiac resynchronization therapy (CRT-D)and/or MitraClip
  • Ability and willingness to provide written informed consent for participation and for the processing of clinical data for research purposes

Who cannot join

  • Age ≤ 18 years or ≥ 75 years
  • Left ventricular ejection fraction > 35%
  • Mild or absent symptoms (New York Heart Association class I-II)
  • Good response to optimized conventional guideline-directed medical therapy
  • Extreme frailty or severe non-reversible disability, or psychiatric or cognitive disorders preventing adherence to follow-up
  • Pregnant or breastfeeding women

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Maria Scandroglio, MD contact

0226437154 / +393473249312

scandroglio.mara@hsr.it

Italy2 sites, 2 recruiting

  • ASST Ospedale Papa Giovanni XXIII

    Bergamo, 24127

    Attilio Iacovoni, MD

    Not yet recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Anna Maria Scandroglio, MD, 02.26437154 / +393473249312, scandroglio.mara@hsr.it

    Recruiting

Other trials in Italy

About this study

Official title: Evaluating Adherence to Guideline- Directed Medical Therapy Using the Four-Pillar Strategy in Patients With Advanced Heart Failure: the Advanced Heart Failure Unified Board (Ad-HUB) Study

A Prospective Observational, Multi-Center, Real-World Pharmacological Study Evaluating Adherence to Guideline-Directed Medical Therapy Using the Four-Pillar Strategy in Patients with Advanced Heart Failure

Read the detailed description

A Prospective Observational, Multi-Center, Real-World Pharmacological Study Evaluating Adherence to Guideline-Directed Medical Therapy Using the Four-Pillar Strategy in Patients with Advanced Heart Failure. Patients will be managed according to routine clinical practice, and no additional treatments are required as part of participation in this study.

As this is an observational study, data on the pharmacological therapies taken by the patients according to routine clinical practice will be recorded, without any modification resulting from participation in the present study. The medications are therefore in the patients' possession and are taken orally according to medical prescription, in accordance with the dosages and indications provided in the package leaflet.

In particular, GDMT consists of a combination of four classes of medications, which each patient may receive: one renin-angiotensin-aldosterone system drug, one beta-blocker, one mineralcorticoid receptor antagonist and one SGLT2 Inhibitor.

Conditions
Heart Failure
Being tested
GDMT, Quality of life questionnaire
Keywords
Medical therapy, Quality of life, Heart failure, mechanical circulatory support
Medical subject headings
Heart Failure

What participants receive

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

  • GDMTDrug

    Also called beta-blocker, mineralcorticoid receptor antagonist, SGLT2 inhibitor, renin-angiotensin-aldosterone system drug

    Percentage of patients receiving GDMT in advanced heart failure

  • Quality of life questionnaireOther

    Absoute Quality of life questionnaire scores (SF 36 questionnaire and EqVAS scale, both validated in Italian language

Study groups in NCT07560982
Study groupRoleWhat they receive
Patients > 18 years and <75 years with advanced heart failure1. Age > 18 and < 75 years 2. Heart failure with left ventricular ejection fraction ≤ 35% 3. Persistent symptoms of heart failure, New York Heart Association class III or IV 4. Requirement for high-dose diuretic therapy, specifically Furosemide > 50 mg/day orally as per routine clinical practice 5. At least one of the following additional indicators of severity or refractoriness: * need for progressive escalation of diuretics, * intolerance to optimized medical therapy, * persistence of symptoms despite advanced treatments such as (but not limited to) cardiac resynchronization therapy (CRT-D)and/or MitraClip 6. Ability and willingness to provide written informed consent for participation and for the processing of clinical data for research purposes
Receives: Drug: GDMT; Other: Quality of life questionnaire

What is being measured

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

  1. assess the adherence to guideline-directed medical therapy in patients with advanced heart failure

    Percentage of patients receiving GDMT in advanced heart failure

    Measured: 3 months, 6 months, 1 year, 2 years, 5 years

Secondary outcomes (1)

  1. assess the level of quality of life in patients under study

    Absoute Quality of life questionnaire scores (short form 36, SF 36, questionnaire and EuroQol Visual Analogue Scale, EqVAS scale, both validated in Italian language). Scored on a 0-100 scale, where higher scores indicate better health.

    Measured: 3 months, 6 months, 1 year, 2 years, 5 years

Timeline

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

  1. First posted1 May 2026
  2. Study start8 May 2026
  3. Primary completion1 Jul 2031 (estimated)
  4. Study completion1 Jul 2036 (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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07560982
Sponsor's protocol ID
Ad-HUB Study
Acronym
ad-HUB
Status last verified
Jul 2026
First submitted
24 Apr 2026
Last updated
6 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • European Society of Cardiology Heart Failure Long-Term Registry (ESC-HF-LT): 1-year follow-up outcomes and differences across regions. Eur J Heart Fail. 2017 Mar;19(3):438. doi: 10.1002/ejhf.772. No abstract available.

    PubMed 28251778

  • Adamo M, Gardner RS, McDonagh TA, Metra M. The 'Ten Commandments' of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2022 Feb 10;43(6):440-441. doi: 10.1093/eurheartj/ehab853. No abstract available.

    PubMed 34922348

  • Tannenbaum C, Ellis RP, Eyssel F, Zou J, Schiebinger L. Sex and gender analysis improves science and engineering. Nature. 2019 Nov;575(7781):137-146. doi: 10.1038/s41586-019-1657-6. Epub 2019 Nov 6.

    PubMed 31695204

  • Piano per l'applicazione e la diffusione della medicina di genere - Ministero della Salute, 2021.

  • Regolamento (UE) 2017/745 sui dispositivi medici.

  • Regione Lombardia. Deliberazione della Giunta Regionale n. XI/3522 del 5 agosto 2020. "Indicazioni e requisiti per l'ulteriore efficientamento organizzativo della rete cardiovascolare regionale". Milano: Regione Lombardia; 2020.Regolamento (UE) 2016/679 del Parlamento Europeo e del Consiglio del 27 aprile 2016 (GDPR).

  • SAGER Guidelines - Sex and Gender Equity in Research.

  • Baksh G, Haydo M, Frazier S et al Improving Utilization of Guideline-Directed Medical Therapy for Heart Failure J Nurse Pract 2024;20:105108

  • Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

    PubMed 35363499

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Università Vita-Salute San Raffaele at 2 sites in Italy.

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 9 inclusion and 6 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 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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 Anna Maria Scandroglio, MD (0226437154 / +393473249312, scandroglio.mara@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assess the adherence to guideline-directed medical therapy in patients with advanced heart failure (time frame: 3 months, 6 months, 1 year, 2 years, 5 years). 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 NCT07560982, which also lists 9 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 Jul 2026.

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