Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01425164
• Other study ID #: IVA-ISCHEMIA
• Status: Recruiting
• Phase: Phase 4
• First received: August 10, 2011
• Last updated: June 27, 2012
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Second University of Naples
• Contact: Gennaro Cice, MD
• Phone: +390815666642
• Email: gennarocice[@]hotmail.com
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Hemodialysis
• Myocardial Ischemia

Intervention

Drug:
• Ivabradine
ivabradine tablets, 5 to 7.5 mg bis-in-die.
• Carvedilol
carvedilol tablets, 12.5 to 25 mg bis-in-die.

Locations

Country	Name	City	State
Italy	Chair of Cardiology Second University of Naples	Naples

Sponsors (2)

Lead Sponsor	Collaborator
Second University of Naples	IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No