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Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

NCT01425164 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2012-06-28

No results posted yet for this study

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

Interventions

DRUG

Ivabradine

ivabradine tablets, 5 to 7.5 mg bis-in-die.

DRUG

Carvedilol

carvedilol tablets, 12.5 to 25 mg bis-in-die.

Sponsors & Collaborators

  • IRCCS San Raffaele

    collaborator OTHER

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Gennaro Cice, MD · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT01425164 on ClinicalTrials.gov