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

Phase 1

• Conditions: Moderate to severe chronic heart failure and reduced left ventricular ejection fraction; MedDRA version: 15.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001689-13-ES
• Lead Sponsor: aboratorios Servier S. L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-26
• Study Completion: 2014-05-15
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 791

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:
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