The rationale and design of the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study

Area of Science:

• Nephrology
• Cardiology
• Clinical Trials

Background:

• Patients undergoing dialysis face high risks of cardiovascular disease and mortality.
• Beta-blockers are commonly used for cardiovascular conditions but their role in dialysis patients is not well-defined.
• The Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study was designed to address this knowledge gap.

Purpose of the Study:

• To determine the feasibility of conducting a large-scale randomized controlled trial (RCT) evaluating the efficacy of carvedilol in dialysis patients.
• To assess the potential of carvedilol in reducing cardiovascular events in this high-risk population.
• To inform the design and parameters of a definitive clinical endpoint study.

Main Methods:

• A randomized, double-blind, placebo-controlled, parallel-group feasibility study.
• Inclusion criteria: dialysis patients (≥3 months) aged ≥50 years, or ≥18 years with diabetes or cardiovascular disease.
• Primary outcome: proportion of participants completing a 6-week carvedilol run-in phase; secondary outcomes included recruitment rates and adherence.

Main Results:

• Recruitment for the BLOCADE Feasibility Study began in May 2011 across 11 sites in Australia and New Zealand.
• The study successfully initiated the process of evaluating patient eligibility and enrollment for a larger trial.

Conclusions:

• The BLOCADE Feasibility Study provides essential data to inform the design of a larger clinical endpoint study.
• Findings will clarify the feasibility of a definitive trial investigating beta-blocker benefits in dialysis patients.
• The study will help establish whether beta-blocking agents offer a therapeutic advantage for this vulnerable patient group.