Evaluation of the effects of 3 successive oral dosages (2.5; 5; 7.5 mg b.i.d.) of ivabradine in patients with stable moderate to severe systolic chronic heart failure treated with beta-blockers. A 9 week pilot, open labelled, international multicenter study

• Conditions: Chronic systolic heart failure; MedDRA version: 3.3Level: PTClassification code 10007558

• Registration Number: EUCTR2005-000103-34-DE
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Selection criteria: Male or female patients over 18 years; syptomatic chronic heart failure class III or IV NYHA since at least 3 months; in stable condition since at least 4 weeks; patients with optimal and stable heart failure treatment for at least 4 weeks including beta-blockers and ACE inhibitors (unless contra-indicated); documented hospital admission within the previous 12 months with discharge diagnosis of chronic heart failure; ischaemic or non ischaemic heart disease; sinus rhythm and heart rate >= 60 bpm; informed consent. Sinus rhythm, heart rate > 60 bpm on resting ECG, left ventricular ejection fraction < 35% from the two-dimensioned echocardiography.
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

Non-selection criteria: Women of childbearing potential not using adequate contraception, unstable cardiovascular condition, significant valvulopathy, active myocarditis, transplanted heart, known severe liver or renal disease, cardiac surgery scheduled within the next 9 weeks, contraindications to the administration of ivabradine, treatment with drug unauthorised during the study.

Study & Design

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