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 systolicdysfunctio
- Conditions
- Moderate to severe chronic heart failure and reduced left ventricular ejection fractionMedDRA version: 16.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-001689-13-LV
- 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
- 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:
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
- 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;<br>- To assess the efficacy of the two formulations over 6 and 12-month periods;<br>- To assess the safety and efficacy of switching ivabradine formulations over a 3-month period;<br>- 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: M06
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety endpoints:<br>- Occurrence of emergent adverse events over 12 months;<br>- Other safety criteria (blood pressure, laboratory test parameters).<br><br>Efficacy endpoints:<br>- HR change from baseline;<br>- Change in clinical symptoms.<br><br>Other endpoints:<br>- For PK characterisation: concentration of ivabradine and its active metabolite;<br>- For Holter evaluation: HR change and abnormalities during awake and sleep periods.;Timepoint(s) of evaluation of this end point: M06, M09 and M12