Evaluating Adherence to Guideline-Directed Medical Therapy in Patients With Advanced Heart Failure (ad-HUB)

May 4, 2026 updated by: Marina Pieri, Università Vita-Salute San Raffaele

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

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

  • Italy
      • Bergamo, Italy, 24127
        • ASST Ospedale Papa Giovanni XXIII
        • Contact:
          • Attilio Iacovoni, MD
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. 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:
  6. need for progressive escalation of diuretics,
  7. intolerance to optimized medical therapy,
  8. persistence of symptoms despite advanced treatments such as (but not limited to) cardiac resynchronization therapy (CRT-D)and/or MitraClip
  9. Ability and willingness to provide written informed consent for participation and for the processing of clinical data for research purposes

Exclusion Criteria:

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

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
Intervention / Treatment
Patients > 18 years and <75 years with advanced heart failure
  1. 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
Drug: GDMT
Percentage of patients receiving GDMT in advanced heart failure
Other Names:
  • SGLT2 inhibitor
  • beta-blocker
  • mineralcorticoid receptor antagonist
  • renin-angiotensin-aldosterone system drug
Other: Quality of life questionnaire
Absoute Quality of life questionnaire scores (SF 36 questionnaire and EqVAS scale, both validated in Italian language

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Percentage of patients receiving GDMT in advanced heart failure
3 months, 6 months, 1 year, 2 years, 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess the level of quality of life in patients under study
Time Frame: 3 months, 6 months, 1 year, 2 years, 5 years
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.
3 months, 6 months, 1 year, 2 years, 5 years

Collaborators and Investigators

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

Sponsor

Università Vita-Salute San Raffaele

Collaborators

Dr. Anna Maria Scandroglio

Investigators

  • Principal Investigator: Anna Maria Scandroglio, MD, IRCCS Ospedale San Raffaele

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2036

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ad-HUB Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Heart Failure

Clinical Trials on GDMT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe