Ivabradine in Hemodialysed Patients With Increased Heart Rate
|ClinicalTrials.gov Identifier: NCT01364077|
Recruitment Status : Unknown
Verified June 2012 by Gennaro Cice, University of Campania "Luigi Vanvitelli".
Recruitment status was: Active, not recruiting
First Posted : June 2, 2011
Last Update Posted : June 21, 2012
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)
|Condition or disease||Intervention/treatment||Phase|
|High Heart Rate||Drug: Ivabradine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy and Safety of Ivabradine in Hemodialysed Patients With Increased Heart Rate|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2011|
|Active Comparator: Ivabradine||
Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
|Placebo Comparator: Control||
- Heart rate [ Time Frame: 1 year ]
- Number of patients that experienced hypotension [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364077
|Chair of Cardiology|
|Naples, Italy, 80100|
|Principal Investigator:||Gennaro Cice, MD||Second Univesity of Naples|