Cardiogenic Shock MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Ivabradine. CAS number: 155974-00-8
Product Name: Ivabradine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVABRADINE
CAS Number: 155974-00-8
Concentration unit: mg milligra
Sponsors
IRICYS- Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine if oral ivabradine in patients with ischemic heart disease, left ventricular ejection fraction depressed with severe acute heart failure (AHF) and indication for intravenous inotropic treatment, reduces pulmonary wedge pressure significantly compared to usual treatment without reducing the cardiac output.;Secondary Objective: 1.Evaluate the safety of ivabradine in patients with severe AHF treated with intravenous catecholamines. We will use parameters such as: development of excessive bradycardia (HR <50 bpm), hypotension (systolic BP <90 mmHg), appearance of ventricular arrhythmias or atrial fibrillation. 2. Evaluate the clinical efficacy of the attenuation of the chronotropic response to catecholamines in the clinical model of severe AHF. We will use surrogate parameters such as: time to inotropic withdrawal, mechanical ventilation time, BNP levels and CRP levels. 3. Analyze total mortality and mortality due to cardiovascular causes in patients with usual treatment or with ivabradine in those patients showing severe AHF who were treated with intravenous catecholamines. 4. Assess the effects of ivabradine on ventricular volumes in the context of severe AHF due to left ventricular dysfunction.;Primary end point(s): Occurrence of emergent adverse events over 1 month.;Timepoint(s) of evaluation of this end point: M01 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Analysis of total mortality, mortality due to cardiovascular disease in relation to treatment with ivabradine in patients with severe AHF treated with intravenous catecholamines. Assess the effects of ivabradine on ventricular volumes in the context of severe AHF due to left ventricular dysfunction.;Timepoint(s) of evaluation of this end point: M18 | — |
Countries
Spain
Contacts
Public ContactCristobal Perez
Clindev
Outcome results
None listed