Heart Rate Control as an Additional Therapeutic Strategy in Patients With Decompensated Heart Failure: a Prospective, Randomized, Double-blinded, Placebo-controlled Study.
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline heart rate
研究概览
简要总结
Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate control in patients with decompensated heart failure (DHF).
详细描述
Sympathetic hyperactivity and consequent increase in heart rate (HR) are physiological responses to low cardiac output in patients with decompensated heart failure (DHF). However, elevated HR may become inappropriate in these patients, increasing myocardial oxygen demand and decreasing diastolic filling time and might lead to hemodynamic deterioration, ventricular dysfunction (tachycardiomyopathy) and clinical deterioration.
Studies show the elevated HR is a predictor of poor prognosis in DHF. Subanalyses of large clinical trials using beta blockers (BBs) demonstrate the adequate control of HR correlates with a better outcome in patients with stable chronic heart failure (HF). However, use of BBs in patients with DHF is limited due to negative inotropic and hypotensive effects of these drugs.
As alternative to BBs, ivabradine has shown to increase survival of patients with chronic stable systolic HF. Compared to BBs, ivabradine has the advantage of "pure" negative chronotropic effect, no effect on myocardial contractility or peripheral vascular resistance. Despite the inhibition of I (f) has been validated as a therapeutic option in patients with stable HF, there are no studies available on this strategy in patients with DHF.
We hypothesized that HR control by ivabradine might improve clinical, hemodynamic and neurohormonal parameters in patients with DHF. The aim of this study was to evaluate the efficacy of HR control with ivabradine in patients with DHF.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sinus node rhythm
- •HR> 80 bpm
- •Hospitalization for DHF
- •Ejection fraction ≤ 40%
- •Sign informed consent
排除标准
- •Systolic blood pressure <85 mmHg
- •Signs of hypoperfusion
- •Dobutamine>15 mcg/Kg/min
- •Acute myocarditis
- •Primary valvular disease requiring surgery
- •Stroke in the last three months
- •Hypertrophic or restrictive cardiomyopathy
- •Sinus node disease
- •Atrial fibrillation or flutter
- •Second or third degree atrio-ventricular blockade
- •Long QT syndrome
- •Severe pulmonary disease
- •Pulmonary embolism in the last three months
- •Need for invasive ventilatory support
- •Septicemia or septic shock
- •Hepatic failure
- •Creatinine > 2.5 mg/dL
- •Hemodialysis
- •Advanced malignancy
- •Pregnancy or lactation
- •Immunosuppressive therapy
- •Use of cytochrome P450 inhibitors
研究组 & 干预措施
ivabradine
I(f) inhibitor, heart rate controller
干预措施: ivabradine (Drug)
placebo
placebo pill will be administered orally twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline heart rate
时间窗: Baseline, day 5 after intervention
Heart rate will be assessed at morning, after 30 minutes of rest, recorded by electrocardiogram.
次要结局
- Change from baseline blood pressure(Baseline, day 5 after intervention)
- Change from baseline ejection fraction(Baseline, day 5 after intervention)
- Change from baseline stroke volume(Baseline, day 5 after intervention)
- Change from baseline creatinine(Baseline, day 5 after intervention)
- Change from baseline brain natriuretic peptide(Baseline, day 5 after intervention)
- Clinical(Up to 6 months)
研究者
Marco Stephan Lofrano Alves
MD
University of Sao Paulo