Ivabradine in Hemodialysed Patients With Increased Heart Rate
A significant association between resting heart rate (HR) and both all-cause mortality and cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the general population and for patients with cardiovascular disease.
Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent study reported that the 48-hr mean HR is an independent predictor of cardiovascular events in normotensive hemodialysis patients.
Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial antianginal effects and mortality reduction linked to HR reduction in ischemic patients.
To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis HR (> 80 bpm)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Ivabradine in Hemodialysed Patients With Increased Heart Rate|
- Heart rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Number of patients that experienced hypotension [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Ivabradine||
Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
|Placebo Comparator: Control||
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364077
|Chair of Cardiology|
|Naples, Italy, 80100|
|Principal Investigator:||Gennaro Cice, MD||Second Univesity of Naples|