Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol
This study is currently recruiting participants.
Verified June 2012 by Second University of Naples
Sponsor:
Second University of Naples
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 22, 2013