NCT01364077

Ivabradine in Hemodialysed Patients With Increased Heart Rate

Efficacy and Safety of Ivabradine in Hemodialysed Patients With Increased Heart Rate

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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. Aim: To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis HR (\> 80 bpm)

Conditions

• High Heart Rate

Interventions

Type	Name	Description
DRUG	Ivabradine	Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
DRUG	Placebo	Matched placebo

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-01-01
• First posted: 2011-06-02
• Last updated: 2012-06-21

Locations

1 site across 1 country: Italy