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Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

Primary Purpose

Coronary Heart Disease, Angina, Hemodialysis

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ivabradine
Carvedilol
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring hemodialysis, coronary heart disease, angina, betablocker, carvedilol, ivabradine

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chair of Cardiology Second University of NaplesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Carvedilol

Ivabradine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2011
Last Updated
June 27, 2012
Sponsor
University of Campania "Luigi Vanvitelli"
Collaborators
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT01425164
Brief Title
Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol
Official Title
Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
Collaborators
IRCCS San Raffaele

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Angina, Hemodialysis
Keywords
hemodialysis, coronary heart disease, angina, betablocker, carvedilol, ivabradine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carvedilol
Arm Type
Active Comparator
Arm Title
Ivabradine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
ivabradine tablets, 5 to 7.5 mg bis-in-die.
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Description
carvedilol tablets, 12.5 to 25 mg bis-in-die.
Primary Outcome Measure Information:
Title
event-free survival
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gennaro Cice, MD
Phone
+390815666642
Email
gennarocice@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gennaro Cice, MD
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chair of Cardiology Second University of Naples
City
Naples
ZIP/Postal Code
80100
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

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