Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Second University of Naples.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
IRCCS San Raffaele
Information provided by (Responsible Party):
Gennaro Cice, Second University of Naples
ClinicalTrials.gov Identifier:
NCT01425164
First received: August 10, 2011
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Coronary Heart Disease
Angina
Hemodialysis
Drug: Ivabradine
Drug: Carvedilol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study

Resource links provided by NLM:


Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • event-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 220
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425164

Contacts
Contact: Gennaro Cice, MD +390815666642 gennarocice@hotmail.com

Locations
Italy
Chair of Cardiology Second University of Naples Recruiting
Naples, Italy, 80100
Sponsors and Collaborators
Second University of Naples
IRCCS San Raffaele
Investigators
Principal Investigator: Gennaro Cice, MD Second University of Naples
  More Information

No publications provided

Responsible Party: Gennaro Cice, Responsible Cardiology Unit ℅ Cappella Cangiani, Second University of Naples
ClinicalTrials.gov Identifier: NCT01425164     History of Changes
Other Study ID Numbers: IVA-ISCHEMIA
Study First Received: August 10, 2011
Last Updated: June 27, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Second University of Naples:
hemodialysis
coronary heart disease
angina
betablocker
carvedilol
ivabradine

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on August 19, 2014