Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

Phase 4

• Conditions: Coronary Heart Disease; Angina; Hemodialysis
• Interventions: Drug: Ivabradine; Drug: Carvedilol

• Registration Number: NCT01425164
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-29
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-27
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• documented CAD evidenced by either coronary angiography (>50% diameter stenosis of a major coronary artery) or a previously documented myocardial infarction
• transient ischemia evidenced by abnormalities during an exercise ECG (standard Bruce protocol), myocardial perfusion scintigraphy, or stress regional wall motion study done within 6 months of study entry

Exclusion Criteria

• unstable angina pectoris
• myocardial infarction or coronary revascularization within 3 months of study entry
• an ECG abnormality interfering with exercise ST-segment interpretation (eg, ST-segment depression >0.5 mm, QRS duration >0.1 second, R-wave amplitude <8 mm,preexcitation,or atrial fibrillation)
• inability to undergo exercise testing
• uncontrolled hypertension
• other serious condition (medical, psychiatric, cognitive, or social)
• symptoms of sufficient severity (Canadian class II or higher) to require antianginal medications other than nitrates
• heart failure
• greater than first-degree atrio-ventricular block, asthma, or other contraindications to betablocker therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivabradine	Ivabradine	-
Carvedilol	Carvedilol	-

Primary Outcome Measures

Name	Time	Method
event-free survival	18 months	primary outcome was event-free survival at 18 months. The following ischemia related events were considered: death, resuscitation from ventricular tachycardia/fibrillation, nonfatal myocardial infarction, hospitalization for unstable angina, aggravation of angina requiring known antianginal therapy, and need for revascularization.

Trial Locations

Locations (1)

Chair of Cardiology Second University of Naples; 🇮🇹 Naples, Italy