Regional and Systemic Hemodynamic Effects of a Long-term Administration of Amlodipine in Patients With Chronic Heart Failure Treated With a Combination of Enalapril, Furosemide and Digoxin
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Humeral blood flow
研究概览
简要总结
Patients with congestive heart failure are usually treated with a combination of an ACE inhibitor (or an AT1 blocking agent), a diuretic and a beta-blocker. However, some patients remain symptomatic despite an optimal treatment with these drugs. In patients who also have coronary heart disease, nitrates or some calcium-channel blockers could help to relieve symptoms. Therefore, the aim of our study is to evaluate the additional benefit induced by a second generation calcium-channel blocker, amlodipine, in patients with chronic heart failure who remain symptomatic despite an optimal treatment.
详细描述
In patients with congestive heart failure, a treatment with ACE inhibitor combined with digoxin and a diuretic has shown benefits on morbidity and mortality. However, 40% of these patients have persistant symptoms. The rationale for the use of calcium channel blockers in patients with chronic heart failure lies in their vasodilating action, antiischemic effect, ability to reduce left ventricular diastolic dysfunction. The objective of our study is to evaluate the regional and systemic hemodynamic, hormonal and vascular effects and the tolerance to stress test of a 3-months treatment with amlodipine. Patients with stable chronic heart failure (III/IV NYHA) and treated with a combination of enalapril, furosemide and digoxin will be randomized to receive amlodipine 5 or 10 mg or a placebo for a 3-months period.
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
- Double
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
- •Patients over 18 years
- •Chronic heart failure with New York Heart Association class III or IV.
- •Ischemic or dilated cardiopathy known for at least 3 months
- •Systolic arterial pressure > 110 mmHg under treatment
- •Stroke volume between 20 and 40% under treatment
- •Informed written consent
排除标准
- •History of allergy to one of the studied pharmaceutical classes
- •History of troubles in ventricular rythm (tachycardia, fibrillation) or acute heart failure
- •Chronic renal, hepatic or respiratory failure
- •Valvulopathy
- •Myocarditis,constrictive pericarditis
- •Life prognosis < 6 months due to a non cardiac pathology
- •Absence of woman contraception, pregnancy, breast-feeding
- •Treatment with calcium channel blockers or antiarrythmics class IC
- •Unstable patient under standardized treatment
- •Unable to do a stress test
结局指标
主要结局
Humeral blood flow
次要结局
- Systemic hemodynamics:
- - Systolic and diastolic arterial pressures
- - Isovolumic relaxation time, pulmonary venous flow
- - Arterial compliance
- - Heart rate and cardiac output
- - Systolic and diastolic left ventricular diameters
- Regional hemodynamics:
- - Ambulatory measure of arterial pressure
- - Carotid, humeral and femoral arterial diameters and flows
- - Renal and hepatosplanchnic blood flow
- Stress test
- Biological variables: ionogram, hormonal and cytokines plasma concentrations
- Functional well-being measure on a Visual Analogue Scale.