Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock (ES-FISH)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Changes from baseline in pulmonary wedge pressure and cardiac output after 24h-treatment with ivabradine or standard of care treatment.
研究概览
简要总结
This is a randomized 1:1 blinded study that evaluate in acute left heart failure-cardiogenic shock patients if ivabradine treatment can reduce pulmonary wedge pressure, without inducing a significant or relevant reduction in cardiac output or increasing the risk of arterial hypotension and with the benefit of allowing a faster titration of heart failure drugs.
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 (Care Provider, Investigator)
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 aged ≥ 18 years, with acute heart failure due to left ventricular systolic dysfunction (LVEF ≤ 40%) in sinus rhythm, baseline HR ≥ 90 bpm, with signs of low peripheral perfusion with indication for intravenous inotropic treatment (catecholamines: dobutamine , adrenaline, dopamine or noradrenaline) and admitted to the Cardiological Intensive Care Unit.
- •Pharmacological treatment and stable hemodynamic situation in the 4 hours before inclusion.
- •Pulmonary wedge pressure ≥ 18 mm Hg and systolic blood pressure > 90 mm Hg.
- •Patient's signature on the consent form.
排除标准
- •Previous treatment with ivabradine (< 48 hours).
- •Known hypersensitivity to ivabradine.
- •Cardiac rhythm different from sinus rhythm.
- •Unstable cardiac rhythm due to paroxysmal atrial fibrillation or atrial flutter, very frequent ventricular or supraventricular premature beats, ventricular tachycardia, 2nd or 3rd degree atrioventricular (AV) block.
- •Severe chronic renal failure (estimated glomerular filtration rate ≤15 ml / min) or on chronic treatment with dialysis.
- •QT interval higher than 450 ms.
- •Sepsis as a probable mechanism of tachycardia and hypotension.
- •Need for urgent cardiac surgery, planned within 72 hours of possible inclusion.
- •Severe aortic stenosis or severe valvular disease that requires surgical correction.
- •Patient must not have received an IV bolus of furosemide immediately before the baseline hemodynamic assessment.
- •Severe hepatic insufficiency.
- •Patient must not be participating in another clinical trial.
- •Concomitant use of potent CYP3A4 inhibitors.
- •Acute anemia or hypovolemia uncorrected.
- •Pregnancy.
研究组 & 干预措施
Ivabradine
Drug: Ivabradine Oral tablets 2.5 mg Dose: 10-15 mg/day Duration: 30 days
干预措施: Ivabradine Oral Tablet (Drug)
Standard of Care
The study drug will be compared with standard of Care treatment
干预措施: Standard of Care treatment (Other)
结局指标
主要结局
Changes from baseline in pulmonary wedge pressure and cardiac output after 24h-treatment with ivabradine or standard of care treatment.
时间窗: 24 hours
Reduction of pulmonary wedge pressure from baseline in both treatment arms (ivabradine arm versus standard of care treatment measured by Swan Ganz balloon flotation catheter)
次要结局
- Severe bradycardia(24 hours)
- Arrhythmias(24 hours)
- Hypotension(24 hours)
- Time to withdrawal of vasoactive drugs(30 days)
- Time needing invasive mechanical ventilation(30 days)
- B-type natriuretic peptide (BNP)(30 days)
- Left ventricular ejection fraction(30 days)
- Cardiovascular mortality(30 days)
- Total mortality(30 days)
研究者
Marcelo Sanmartín Fernández
Director Acute Coronary Syndrome Process
Hospital Universitario Ramon y Cajal