Effectiveness and Safety on Cardiac Frecuency Control With Ivabradine on the Cardiogenic Shock.

Phase 1

Conditions: Cardiogenic Shock
MedDRA version: 20.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2018-000191-15-ES

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

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.
Pregnancy.