Evaluating Adherence to Guideline-Directed Medical Therapy in Patients With Advanced Heart Failure (ad-HUB)
2026年7月1日 更新者：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
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
300
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Anna Maria Scandroglio, MD
- 电话号码：0226437154 / +393473249312
- 邮箱：scandroglio.mara@hsr.it
学习地点
-
-
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Bergamo、意大利、24127
- 尚未招聘
- ASST Ospedale Papa Giovanni XXIII
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接触：
- Attilio Iacovoni, MD
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Milan、意大利、20132
- 招聘中
- IRCCS Ospedale San Raffaele
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接触：
- Anna Maria Scandroglio, MD
- 电话号码：02.26437154 / +393473249312
- 邮箱：scandroglio.mara@hsr.it
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
Patients with advanced heart failure, the proportion of patients receiving GDMT will be assessed.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients > 18 years and <75 years with advanced heart failure
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Percentage of patients receiving GDMT in advanced heart failure
其他名称：
Absoute Quality of life questionnaire scores (SF 36 questionnaire and EqVAS scale, both validated in Italian language
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
assess the adherence to guideline-directed medical therapy in patients with advanced heart failure
大体时间：3 months, 6 months, 1 year, 2 years, 5 years
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Percentage of patients receiving GDMT in advanced heart failure
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3 months, 6 months, 1 year, 2 years, 5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
assess the level of quality of life in patients under study
大体时间：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
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Anna Maria Scandroglio, MD、IRCCS Ospedale San Raffaele
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月8日
初级完成 (估计的)
2031年7月1日
研究完成 (估计的)
2036年7月1日
研究注册日期
首次提交
2026年4月24日
首先提交符合 QC 标准的
2026年4月24日
首次发布 (实际的)
2026年5月1日
研究记录更新
最后更新发布 (实际的)
2026年7月6日
上次提交的符合 QC 标准的更新
2026年7月1日
最后验证
2026年7月1日
更多信息
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