The Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study

The BLOCADE Feasibility Study aims to inform the final design of a randomised controlled trial with clinically important endpoints to determine whether therapy with the beta-blocker carvedilol will reduce the cardiovascular morbidity and mortality of patients receiving dialysis. The major aim of the Feasibility Study is thus to determine the tolerability of carvedilol in this population. Participants will be patients over the age of 50 years, or those over 18 years with either diabetes or cardiovascular disease. After a run-in phase, patients will be randomised to carvedilol, titrated to the maximum tolerated dose or 25mg twice daily, or placebo titrated in an identical fashion. Patients will be followed for 12 months to determine tolerability in terms of the proportion of participants not tolerating carvedilol in the Run-in Phase and post Randomisation, as well as the incidence of major adverse effects. Other data such as rates of dropping out or dropping in will specifically inform the final sample size calculation, and data regarding recruitment rates and the numbers of patients tolerating each specific dose of carvedilol will assist with logistics. The Feasibility Study will recruit 150 participants and follow them for 12 months, at which time they will have a final study visit, then undergo supervised down-titration then cessation of study drug. The protocol of the proposed Clinical End-point Study will be written based on data from the Feasibility Study.