Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure: the Coffee-it Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Progression of CHF
研究概览
简要总结
To evaluate canrenone effects compared to other therapies on cardiovascular mortality in patients with congestive heart failure and preserved systolic function after 12 years of evaluation.
详细描述
The investigators will verify patients with cardiac heart failure (CHF) and preserved systolic function and each patient must have all clinical evaluation through basal measurements of blood pressure, heart rate, biochemical tests, and color Doppler echocardiographic parameters for at least 12 years.
The investigators will evaluate the effects of an aldosterone antagonist as canrenone compared to a group without canrenone and the investogators will verify how many patients reported cardiovascular mortality or will survive.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with CHF
- •preserved systolic function (FE ≥ 45%)
排除标准
- •severe hypertension identified by blood pressure ≥180/110 mmHg
- •patients with impaired systolic function (FE < 45%)
- •history of active hepatitis or cirrhosis
- •impaired renal function
- •hyperpotassemia
研究组 & 干预措施
With canrenone
Patients with canrenone
干预措施: Canrenone (Drug)
结局指标
主要结局
Progression of CHF
时间窗: 12 years
Echocardiografic data
Haemodynamic data
时间窗: 12 years
Systolic blood pressure (SBP, Diastolic blood pressure (DBP), Heart rate (HR)
Metabolic data
时间窗: 12 years
fasting plasma glucose (FPG), total cholesterol (TC), HDL-cholesterol (HDL-C), triglycerides (Tg), LDL-cholesterol (LDL-C), lipoprotein (a) \[Lp(a)\],
Renal function
时间窗: 12 years
Sodium, Potassium, Creatinine, Uric acid
Endocrine data
时间窗: 12 years
Aldosterone, Plasma brain natriuretic peptide (BNP), Plasma renin activity (PRA)
Cardiovascular mortality
时间窗: 12 years
Register data
Survival
时间窗: 12 years
Register data
次要结局
未报告次要终点
研究者
Giuseppe Derosa
MD, PhD, FESC
University of Pavia