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.|
|ClinicalTrials.gov Identifier: NCT01425164|
Recruitment Status : Unknown
Verified June 2012 by Gennaro Cice, Second University of Naples.
Recruitment status was: Recruiting
First Posted : August 29, 2011
Last Update Posted : June 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease Angina Hemodialysis||Drug: Ivabradine Drug: Carvedilol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Active Comparator: Carvedilol||
carvedilol tablets, 12.5 to 25 mg bis-in-die.
ivabradine tablets, 5 to 7.5 mg bis-in-die.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01425164
|Contact: Gennaro Cice, MDfirstname.lastname@example.org|
|Chair of Cardiology Second University of Naples||Recruiting|
|Naples, Italy, 80100|
|Principal Investigator:||Gennaro Cice, MD||University of Campania "Luigi Vanvitelli"|