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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- assess the adherence to guideline-directed medical therapy in patients with advanced heart failure
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patients > 18 years and <75 years with advanced heart failure
- 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
干预措施: Quality of life questionnaire (Other)
Patients > 18 years and <75 years with advanced heart failure
- 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
干预措施: GDMT (Drug)
结局指标
主要结局
assess the adherence to guideline-directed medical therapy in patients with advanced heart failure
时间窗: 3 months, 6 months, 1 year, 2 years, 5 years
Percentage of patients receiving GDMT in advanced heart failure
次要结局
- assess the level of quality of life in patients under study(3 months, 6 months, 1 year, 2 years, 5 years)
研究者
Marina Pieri
MD
Università Vita-Salute San Raffaele