Effectiveness and Safety on Cardiac Frecuency Control With Ivabradine on the Cardiogenic Shock. (ES-FISH) - (ES-FISH)

IRICYS- Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal0 个研究点目标入组 22 人开始时间: 2018年4月20日最近更新: 2018年6月18日

适应症

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 22
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•Previous treatment with ivabradine (< 48 hours).
•Known hypersensitivity to Ivabradine.
•Sickness not corrected by pacemaker.
•Rhythm different from sinus rhythm.
•Unstable cardiac rhythm due to paroxysmal atrial fibrillation or atrial flutter, very frequent ventricular or supraventricular extrasystole, ventricular tachycardia, 2nd or 3rd degree AV block.
•Severe chronic renal failure (FGE =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.
•Severe hepatic insufficiency.
•Concomitant use of potent CYP3A4 inhibitors.
•Acute anemia or hypovolemia uncorrected.

发起方

IRICYS- Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal