Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

Study Overview
=================
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.

Official Title
-----------------
Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study

Conditions
-----------------
Coronary Heart Disease, Angina, Hemodialysis

Intervention / Treatment
-----------------
* Drug: Ivabradine
* Drug: Carvedilol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carvedilol<br> | Drug: Carvedilol<br>* carvedilol tablets, 12.5 to 25 mg bis-in-die.<br>|
| Experimental: Ivabradine<br> | Drug: Ivabradine<br>* ivabradine tablets, 5 to 7.5 mg bis-in-die.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event-free survival | 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. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, coronary heart disease, angina, betablocker, carvedilol, ivabradine