Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation in patients with chronic heart failure and left ventricular systolic dysfunctio

Conditions: Moderate to severe chronic heart failure and reduced left ventricular ejection fraction
MedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 14.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-001689-13-IT

Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 700

Inclusion Criteria

Women or men; - Age = 18 years; - Symptomatic CHF, NYHA class II, III or IV for at least 6 weeks prior to selection; - CHF from all aetiologies except from congenital heart disease or from severe aortic or mitral valva disease; - Normal sinus rhythm; - Resting heart rate =75bpm; - Documented left ventricular systolic dysfunction.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 434
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 266

Exclusion Criteria

Women who are pregnant, breast-feeding or women of childbearing potential not using estro-progestative oral or intra-uterine contraception or implants, or women using estroprogestative or intra-uterine contraception or implants but who consider stopping it during the planned duration of the study. - Contra-indication to ivabradine, ivabradine not recommended or not effective, or requirement for a not recommended concomitant treatment (cf ivabradine SmPC); - Previous cardiac transplantation or on list for cardiac transplantation; - Patient treated with ivabradine in the month preceding the selection.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the safety profiles of the ivabradine modified release (MR) formulation and ivabradine immediate release (IR) formulation over a 6-month period;Secondary Objective: To assess the safety of the two formulations over a 12-month period; - To assess the efficacy of the two formulations over 6 and 12-month periods; - To assess the safety and efficacy of switching ivabradine formulations over a 3-month period; - To assess in a subset of patients the pharmacokinetic profile and the cardiac safety from 24-hour Holter ECG of the two formulations.;Primary end point(s): Occurrence of emergent adverse events over 6 months;Timepoint(s) of evaluation of this end point: M0

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety endpoints: - Occurrence of emergent adverse events over 12 months; - Other safety criteria (blood pressure, laboratory test parameters). Efficacy endpoints: - HR change from baseline; - Change in clinical symptoms. Other endpoints: - For PK characterisation: concentration of ivabradine and its active metabolite; - For Holter evaluation: HR change and abnormalities during awake and sleep periods;Timepoint(s) of evaluation of this end point: M06, M09 and M12

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