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Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01425164
Recruitment Status : Unknown
Verified June 2012 by Gennaro Cice, University of Campania "Luigi Vanvitelli".
Recruitment status was:  Recruiting
First Posted : August 29, 2011
Last Update Posted : June 28, 2012
IRCCS San Raffaele
Information provided by (Responsible Party):
Gennaro Cice, University of Campania "Luigi Vanvitelli"

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Angina Hemodialysis Drug: Ivabradine Drug: Carvedilol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study
Study Start Date : January 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Carvedilol Drug: Carvedilol
carvedilol tablets, 12.5 to 25 mg bis-in-die.

Experimental: Ivabradine Drug: Ivabradine
ivabradine tablets, 5 to 7.5 mg bis-in-die.

Primary Outcome Measures :
  1. event-free survival [ Time Frame: 18 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01425164

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Contact: Gennaro Cice, MD +390815666642

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Chair of Cardiology Second University of Naples Recruiting
Naples, Italy, 80100
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
IRCCS San Raffaele
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Principal Investigator: Gennaro Cice, MD University of Campania "Luigi Vanvitelli"

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Responsible Party: Gennaro Cice, Responsible Cardiology Unit ℅ Cappella Cangiani, University of Campania "Luigi Vanvitelli" Identifier: NCT01425164     History of Changes
Other Study ID Numbers: IVA-ISCHEMIA
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012
Keywords provided by Gennaro Cice, University of Campania "Luigi Vanvitelli":
coronary heart disease
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Arterial Occlusive Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists