NCT01425164

Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Heart Disease
• Angina
• Hemodialysis

Interventions

Type	Name	Description
DRUG	Ivabradine	ivabradine tablets, 5 to 7.5 mg bis-in-die.
DRUG	Carvedilol	carvedilol tablets, 12.5 to 25 mg bis-in-die.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-08-29
• Last updated: 2012-06-28

Locations

1 site across 1 country: Italy