A Randomised, Single Blind, Multicentre, 9-month, Phase IV Study, Comparing Treatment Guided by Clinical Symptoms and Signs and NT-proBNP vs Treatment Guided by Clinical Symptoms and Signs Alone, in Patients With Heart Failure (HF) and Left Ventricular Systolic Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9)
研究概览
简要总结
The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic dysfunction
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
- Single (Participant)
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
- •Female/male, over 18 years with previously verified HF with left ventricular systolic dysfunction.
- •New York Heart Association(NYHA) class II-IV,
- •NTproBNP males>800 ng/L, females >1000 ng/L
排除标准
- •Planned CV hospitalisation, stroke or acute myocardial infarction (MI) last 3 months,
- •Mitral/aortic stenosis,
- •Patients already receiving optimal HF treatment,
- •Severe reduction of kidney function
研究组 & 干预措施
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Captopril (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Enalapril (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Lisinopril (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Ramipril (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Trandolapril (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Bisoprolol (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Diuretics (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Carvedilol (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Metoprolol succinate (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Candesartan (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Valsartan (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Eplerenone (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Spironolactone (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Diuretics (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: HF treatment according to Swedish guidelines (Drug)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: Blood samples (Procedure)
Guided by NT-proBNP
Treatment guided by clinical symptoms and signs + NTproBNP
干预措施: The Kansas City Cardiomyopathy Questionnaire (KCCQ) (Procedure)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Captopril (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Enalapril (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Lisinopril (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Ramipril (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Trandolapril (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Bisoprolol (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Carvedilol (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Metoprolol succinate (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Candesartan (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Valsartan (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Eplerenone (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Spironolactone (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: HF treatment according to Swedish guidelines (Drug)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: Blood samples (Procedure)
Not Guided by NT-proBNP
Treatment guided by clinical symptoms and signs
干预措施: The Kansas City Cardiomyopathy Questionnaire (KCCQ) (Procedure)
结局指标
主要结局
Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9)
时间窗: 9 months
The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented
次要结局
- Number of CV Deaths(9 months)
- Number of Days in Hospital for CV Reason(9 months)
- Changes in Heart Failure Symptoms(9 months and baseline)
- Changes in NT-proBNP Values Over Time in All Patients(9 months and baseline)
- Changes in Health-related Quality of Life(9 months and baseline)
- Total Number of Titration Steps in Prescribed Heart Failure Treatment(9 months)
- Discontinuations(9 months)