Ivabradine in Hemodialysed Patients With Increased Heart Rate

Phase 4

• Conditions: High Heart Rate
• Interventions: Drug: Placebo; Drug: Ivabradine

• Registration Number: NCT01364077
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-01
• Study First Submitted: 2011-05-25
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-20
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Dialysis patients
• Sinus rhythm
• Pre-dialytic Heart rate > 80 bpm

Exclusion Criteria

• Atrial fibrillation/atrial flutter
• Heart failure
• Valvular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	-
Ivabradine	Ivabradine	-

Primary Outcome Measures

Name	Time	Method
Heart rate	1 year

Secondary Outcome Measures

Name	Time	Method
Number of patients that experienced hypotension	1 year

Trial Locations

Locations (1)

Chair of Cardiology; 🇮🇹 Naples, Italy