Evaluating Adherence to Guideline-Directed Medical Therapy in Patients With Advanced Heart Failure
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: GDMT, Quality of life questionnaire.
- Кому может быть актуально
- Состояния в реестре: Heart Failure. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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
Подробное описание
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.
Вмешательства
- Препарат GDMT
Percentage of patients receiving GDMT in advanced heart failure - Другое Quality of life questionnaire
Absoute Quality of life questionnaire scores (SF 36 questionnaire and EqVAS scale, both validated in Italian language
Первичные конечные точки
- assess the adherence to guideline-directed medical therapy in patients with advanced heart failure [Срок оценки: 3 months, 6 months, 1 year, 2 years, 5 years]
Вторичные конечные точки (1)
- assess the level of quality of life in patients under study [Срок оценки: 3 months, 6 months, 1 year, 2 years, 5 years]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 2 центра
- ASST Ospedale Papa Giovanni XXIII — Bergamo
- IRCCS Ospedale San Raffaele — Milan
Публикации
- 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
- 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
- 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
- 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
Идентификаторы
NCT: NCT07560982 · Ad-HUB Study