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Ivabradine in Hemodialysed Patients With Increased Heart Rate

NCT01364077 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-06-21

No results posted yet for this study

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

DRUG

Ivabradine

Ivabradine 5 mg BID titrated to 7.5 mg if tolerated

DRUG

Placebo

Matched placebo

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Gennaro Cice, MD · Second Univesity of Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01364077 on ClinicalTrials.gov