Effects of ivabradine IV versus placebo on haemodynamic parameters in patients with a low cardiac output syndrome following planned coronary artery bypass surgery and requiring positive inotropic treatment. A phase II, single blind, exploratory, multicentre study.

Phase 1

• Conditions: Coronary Artery Disease patients presenting a low cardiac output syndrome following a planned coronary artery bypass graft and requiring a positive inotropic treatment with dobutamine administered as first line inotropic therapy.; MedDRA version: 12.1Level: LLTClassification code 10068176Term: Coronary artery bypass graft; MedDRA version: 12.1Level: PTClassification code 10024899Term: Low cardiac output syndrome

• Registration Number: EUCTR2009-018175-14-FR
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-02
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Male or female of non childbearing potential,
- ­Aged >= 18 years and < 75 years,
- Patients presenting a LCOS following a planned CABG and requiring positive inotropic treatment with dobutamine as first line inotropic therapy,
- ­normal sinus rhythm as documented by a resting standard 12-lead ECG,
­- coronary artery disease as documented by the coronary angiography,
­- left ventricular ejection fraction >= 20% >= 40%, documented by a trans-thoracic echocardiography within 1 month prior to the study enrolment,
- HR >= 100 bpm after initiation of dobutamine infusion

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

­- Patient with a clinically significant heart disease other than coronary heart disease
­- History of recurrent episodes of ventricular arrhythmia
- ­History of permanent complete arrhythmia due to atrial fibrillation, flutter pacemaker or cardioverter-defibrillator implantation,
­- History of atrioventricular block of 2nd or 3rd degree,
­- Trifascicular block and PR > 240 msec,
­- Symptomatic hypotension or hypotension with SBP < 85 mmHg,
­- Severe or uncontrolled hypertension
- LCOS occuring after a septic shock

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of ivabradine administered by intravenous route in Coronary Artery Disease patients presenting a Low Cardiac Output Syndrome following a planned coronary artery bypass graft and requiring a positive inotropic treatment with dobutamine administered as first line inotropic therapy.;Secondary Objective: ­- To confirm that the efficacy of the inotropic treatment on haemodynamics is not altered when associated with ivabradine,<br>­- To optimize the inotropic treatment by reducing the related induced excessive tachycardia,<br>­- To evaluate the effect of ivabradine versus placebo on the reduction of early cardiovascular events,<br>­- To compare the safety profile of ivabradine to placebo.;Primary end point(s): The number and percentage of patients responders i.e. patients whose heart rate is within the range of 80 to 90 bpm: <br>­- for at least 30 minutes during ivabradine/placebo infusion <br>­- and/or allowing an increase of the inotropic treatment with dobutamine.<br>