Chronic systolic heart failure MedDRA version: 3.3 Level: PT Classification code 10007558
Conditions
Interventions
Trade Name: PROCORALAN
Product Name: ivabradine
Product Code: ivabradine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ivabradine
CAS Number: 155974-00-8
Current Sponsor code: S16257-02
Sponsors
Institut de Recherches Internationales Servier
Laboratorios Servier S.L. (For Spain only)
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the effects of 3 oral dosages (2.5; 5; 7.5 mg b.i.d.) of ivabradine on heart rate, systolic and diastolic blood pressure, left ventricular volumes and function in patients with stable moderate to severe systolic chronic heart failure treated with beta-blockers.;Secondary Objective: The secondary objectives are: - to assess in these patients the effects of ivabradine on: · functional capacity: evaluated with the New York Heart Association (NYHA) classification, · clinical symptoms: overall clinical assessment according to the patient and to the investigator respectively, · neurohormones: Brain Natriuretic Peptide (BNP) measurement - to evaluate in these patients the safety of ivabradine, - to assess in these patients plasma pharmacokinetic parameters for ivabradine and its metabolite S 18982. ;Primary end point(s): Efficacy measurements: - Heart rate (12 leads-ECG), - Left ventricular size and function (Echocardiography). | — |
Countries
Germany, Italy
Outcome results
None listed