NCT05556031尚未招募不适用
The Reduction of Decompensation and Unnecessary Cardiac Failure Emergency Admissions: Ambulatory Heart Failure Service Model
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Clinical outcome
研究概览
简要总结
The aim of the study is to assess the efficacy of this new ambulatory service model in reducing heart failure hospitalization (HHF), improving clinical as well as functional outcomes of post-discharge patients with Heart Failure of reduced ejection fraction (HFrEF) and Heart failure with preserved Ejection Fraction (HFpEF).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dyspnoea (exertional or at rest) and 2 of the following signs:
- •Congestion on chest X-ray
- •Rales on chest auscultation
- •Clinically relevant oedema (e.g. ≥1+ on a 0 to 3+ scale)
- •Elevated jugular venous pressure
- •NT-proBNP ≥300 pg/mL (Patients with AF: NT-proBNP ≥900 pg/mL)
- •Heart failure hospitalization that requires the treatment of a minimum single dose of 40 mg of i.v. furosemide (or equivalent i.v loop diuretics)
- •Ambulatory patients
排除标准
- •Cardiogenic shock required inotropics
- •Cardiac mechanical support implantation like LVAD
- •Life expectancy less than 1 year due to underlying significant comorbidities like metastatic cancer or end-stage COPD
- •Haemodynamically severe uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study.
- •End stage renal failure or eGFR <15 mL/min/1.73m2 as measured during index hospitalization or requiring dialysis
结局指标
主要结局
Clinical outcome
时间窗: 90 days
A composite of all-cause mortality, number of heart failure events (including hospitalization for heart failure (HHF), urgent heart failure visits and unplanned outpatient visits), time to first heart failure event will be aggregated to evaluate overall clinical outcome
次要结局
- Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)(1 year)
- NT-proBNP level(1 year)
- Risk of Heart failure(1 year)
- Quality adjusted Life years gained(1 year)
- Change in overall Cardiac function(90 days)
- Major Adverse Cardiovascular Event(1 year)
- Hypertensive heart failure (HHF)(90 days after initial hospital discharge)
- Change in 6 minute hall walk (6MHW)(90 days)
研究者
Professor Bryan Ping Yen YAN
Professor
Chinese University of Hong Kong
研究点 (1)
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