Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol
Recruitment status was Recruiting
In hemodialysed patients, coronary heart disease is the leading cause of mortality and morbidity. Most of the commonly used drug for ischemia are used in this patients, but few prospective data are available. Among anti-ischemic drugs betablocker provided evidence of beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of benefit in general population, but no study is available in dialysis patients. Aim of the present study is to compare in a randomized, double-blind, parallel group trial the effects of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed population of patients with established coronary heart disease.
Coronary Heart Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study|
- event-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]primary outcome was event-free survival at 18 months. The following ischemia related events were considered: death, resuscitation from ventricular tachycardia/fibrillation, nonfatal myocardial infarction, hospitalization for unstable angina, aggravation of angina requiring known antianginal therapy, and need for revascularization.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Carvedilol||
carvedilol tablets, 12.5 to 25 mg bis-in-die.
ivabradine tablets, 5 to 7.5 mg bis-in-die.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425164
|Contact: Gennaro Cice, MDfirstname.lastname@example.org|
|Chair of Cardiology Second University of Naples||Recruiting|
|Naples, Italy, 80100|
|Principal Investigator:||Gennaro Cice, MD||Second University of Naples|