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

NCT07560982 | Not Yet Recruiting FDA Drug

• 1 other identifier: Ad-HUB Study
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Heart Failure

Keywords

Medical therapy; Quality of life; Heart failure; mechanical circulatory support

Outcome Measures

Primary Outcomes (1)

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

  Percentage of patients receiving GDMT in advanced heart failure

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

Secondary Outcomes (1)

• assess the level of quality of life in patients under study

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

Study Arms (1)

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; Other: Quality of life questionnaire

Interventions

GDMT DRUG

Percentage of patients receiving GDMT in advanced heart failure

Also known as: beta-blocker, mineralcorticoid receptor antagonist, SGLT2 inhibitor, renin-angiotensin-aldosterone system drug

Patients > 18 years and <75 years with advanced heart failure

Quality of life questionnaire OTHER

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

Patients > 18 years and <75 years with advanced heart failure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead
• Dr. Anna Maria Scandroglio: collaborator

Study Sites (2)

ASST Ospedale Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Related Publications (9)

• 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.

  PMID: 28251778 BACKGROUND

• 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.

  PMID: 34922348 BACKGROUND

• 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.

  PMID: 31695204 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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).

  BACKGROUND

• SAGER Guidelines - Sex and Gender Equity in Research.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 35363499 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Adrenergic beta-Antagonists; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Hypoglycemic Agents

Study Officials

• Anna Maria Scandroglio, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Maria Scandroglio, MD

CONTACT

0226437154 / +393473249312; scandroglio.mara@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2036
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)