Heart failure
Conditions
Interventions
Trade Name: Procoralan
Pharmaceutical Form: Coated tablet
INN or Proposed INN: IVABRADINE
CAS Number: 155974-00-8
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5
Sponsors
University Hospital Olomouc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: adults with ICD and EF =35% a resting heart rate > 75/min with a standard up-titrated HF treatment (diuretics, verospiron, betablockers, ACEI) 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: permanent atrial fibrillation, recent (<1 month) myocardial infarction or acute heart failure decompensation, clinically important liver insufficiency, combination with strong CYP3A4 inhibitors, Recent ICD implantation (<1 month). Women in fertile age without proper contraception, pregnant or breastfeeding women. Other concomitant illness which limits prognosis to less then 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Decrease in arrhythmia incidence in heart failure patients using ivabradine;Secondary Objective: Antiremodelation effect on left ventricle;Primary end point(s): Decrease in arrhythmia incidence in the group treated with ivabradine Decrease in ICD therapies delivered by ICD;Timepoint(s) of evaluation of this end point: At 6 months and in 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Hemodynamical effect of ivabradine evaluated clinically and echocardiographically;Timepoint(s) of evaluation of this end point: At 6 months and in 12 months | — |
Countries
Czech Republic
Contacts
Public ContactDirectoriate of University Hospital
University Hospital Olomouc
Outcome results
None listed