Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

NCT01425164 | Unknown Phase 4

• 1 other identifier: IVA-ISCHEMIA
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Angina; Hemodialysis

Keywords

hemodialysis; coronary heart disease; angina; betablocker; carvedilol; ivabradine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Carvedilol

ACTIVE COMPARATOR

Drug: Carvedilol

Ivabradine

EXPERIMENTAL

Drug: Ivabradine

Interventions

Ivabradine DRUG

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

Ivabradine

Carvedilol DRUG

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

Carvedilol

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• IRCCS San Raffaele: collaborator

Study Sites (1)

Chair of Cardiology Second University of Naples

Naples, 80100, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Angina Pectoris

Interventions

Ivabradine; Carvedilol

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Study Officials

• Gennaro Cice, MD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gennaro Cice, MD

CONTACT

+390815666642; gennarocice@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible Cardiology Unit ℅ Cappella Cangiani

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 29, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

IT (1)