Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

University of Campania "Luigi Vanvitelli"

Status and phase: Unknown; Phase 4

Conditions: Hemodialysis; Coronary Heart Disease; Angina

Treatments: Drug: Carvedilol; Drug: Ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT01425164

IVA-ISCHEMIA

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups

Carvedilol

Active Comparator group

Treatment:

Drug: Carvedilol

Ivabradine

Experimental group

Treatment:

Drug: Ivabradine