A Prospective Randomized Multicenter Controlled Study to Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure With Reduced Ejection Fraction.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,009
- 试验地点
- 2
- 主要终点
- Guideline adherence indicator at 6months
研究概览
简要总结
The period of about a month after the discharge of acute heart failure patients is defined as a transition time. During this period, the patient has a high mortality rate and a readmission rate because the patient is not stabilized. In the United States and Europe, the readmission rate is more than 25% within 30 days, and the mortality rate within 30 days after discharge is three times that of patients with chronic heart failure.
The TRANS-HF is a prospective, randomized, multi-center, controlled study, which enrolls patients with acute heart failure with reduced ejection fraction.
The objective of TRANS-HF is to improve GAI at six months through three interventions: pre-discharge checklist, heart failure education, and telephone monitoring before the first outpatient visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive hospitalized adult heart failure patients who fulfill one of 1-3 and satisfy 4-5 simultaneous
- •Inclusion Criteria:
- •Symptoms of heart failure
- •Signs of heart failure
- •Lung congestion in Chest-X-ray
- •Objective finding of structural and/or functional disorder of the heart or elevated natriuretic peptide levels
- •Left ventricular ejection fraction less than 40%
排除标准
- •Patients younger than 19 years old
- •Patients who do no consent
结局指标
主要结局
Guideline adherence indicator at 6months
时间窗: 6months
the point of Guideline adherence indicator. Definition of GAI strata : Level of guideline-adherent treatment will be measured by guideline adherence indicator (GAI) such as 0/3, 1/3, 2/3, and 3/3. This GAI data will be obtained once after all prescription data has been collected. It will include whether or not prescribed medication of ≥50% of target dose : 0 points for non-prescription in the absence of contra-indications, 0.5 points for use of \<50% of target dosage (\<100% of target dose for MRA as the majority of patients were treated with ≥50% of target dose of MRA) or 1 point for use in ≥50% of target dosage (target dose for MRA). Non-administration of recommended drugs due to specific contraindications or intolerance will be scored as adherence to guidelines.
次要结局
- Guideline adherence indicator at 1month(1month after discharge)
- Heart failure rehospitalization(up to 6 months)
- KCCQ(The Kansas City Cardiomyopathy Questionnaire) at discharge(0 day (at discharge))
- EQ-5D(The EuroQoL five-dimensional instrument) at discharge(0 day (at discharge))
- EQ-5D(The EuroQoL five-dimensional instrument) at 6 months(6 months after discharge)
- Guideline adherence indicator at discharge(0 day (at discharge))
- KCCQ(The Kansas City Cardiomyopathy Questionnaire) at 6 months(6 months after discharge)
- All-cause death(up to 6 months)
- Cardiovascular death(up to 6 months)
- Composite end-point(up to 6 months)
- Cardiovascular rehospitalization(up to 6 months)