A randomised controlled trial of the beta-blocker carvedilol versus placebo to reduce cardiovascular morbidity and mortality in high-risk patients receiving dialysis: the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study

Australasian Kidney Trials Network- University of Queensland0 sites150 target enrollmentApril 16, 2009

Conditionscardiovascular disease end-stage kidney diseasehaemodialysisperitoneal dialysis end-stage kidney disease haemodialysis peritoneal dialysis Renal and Urogenital - Kidney disease Cardiovascular - Other cardiovascular diseases

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: cardiovascular disease
Sponsor: Australasian Kidney Trials Network- University of Queensland
Enrollment: 150
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 16, 2009

End Date

July 1, 2014

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Australasian Kidney Trials Network- University of Queensland

Eligibility Criteria

Inclusion Criteria

•1\. The person has end\-stage kidney disease and is receiving either haemodialysis or peritoneal dialysis 2\. At the time of signing the consent form, the person is: i) Age \>50 years, OR ii) Age \>18 years with diabetes, OR iii) Age \>18 years and has clinical features of cardiovascular disease (myocardial infarction or ischaemic heart disease, ischaemic stroke or peripheral arterial disease).

Exclusion Criteria

•1\. Scheduled for live donor transplant within six months. 2\. Experienced a cardiovascular event in the previous 3 months. Cardiovascular events include: myocardial infarction, admission for unstable angina, coronary revascularisation procedure, peripheral arterial revascularisation procedure or stroke. 3\. Definite contra\-indication to beta\-blockers, such as: i) second or third degree atrioventricular block unless treated with a permanent pacemaker ii) sick sinus syndrome unless treated with a permanent pacemaker iii) clinically significant reversible bronchospasm iv) previous intolerance to beta\-blockers v) other contra\-indication 4\. Currently taking a beta\-blocker, verapamil, diltiazem or moxonidine and the treating nephrologist does not wish to stop these medications in order to enter the trial. 5\. Considered by the treating nephrologist to be clinically or haemodynamically unstable for the study. 6\. Unstable target weight (defined by a change of \>2\.0kg in target base weight over the preceding month). 7\. Severe hepatic dysfunction (transaminases \>3x higher than the upper normal limit) on the most recent liver function tests (if performed within 3 months). 8\. Already involved in a clinical trial where the intervention being trialled is likely to confound the outcome of this trial. 9\. Considered by the treating physician to have a life expectancy of less than 12 months. 10\. Inability to provide consent or follow study instructions due to psychological illness or condition. 12\. Pregnant or planning to be pregnant during the trial period.