PS-C20-1: NIGHT-TIME BLOOD PRESSURE-LOWERING DRUG TREATMENT FOR THE PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES: A PROPOSED RANDOMISED CONTROLLED TRIAL

Abstract

Rationale: An increase of 20 mmHg in night-time blood pressure (BP) and a pattern of a higher BP at night than during the day was independently associated with an increased risk of 21% and 48% cardiovascular disease respectively. This association was more likely to present in type 2 diabetes mellitus (DM) patients. Objectives: This proposed study aims to examine the effect of taking night-time BP lowering drug treatment targeting night-time BP profile as compared to the conventional once-daily morning dose on the prevention of cardiovascular disease event in diabetes. Design: A Prospective Randomized Open-label with Blinding of Endpoint assessment. Methods: Men and women diagnosed with type 2 DM patients who are 60 years or over in Australia will be included in the trial. As per the current Australia guideline, these individuals meet the criteria to initiate BP lowering drug treatment for CVD prevention. The trial will be conducted as a “digital clinical trial” for participant recruitment, retention and data collection through an interactive web page platform. Participants will be referred by their health practitioners. Eligible participants will be randomised to either night-time or morning dosing treatments with a 1:1 ratio: a) Taking all of their usual once-daily dose of BP-lowering medications at bedtime (between 20:00 and midnight) or b) Taking a once-daily dose of BP-lowering medications upon awakening (between 06:00 and 10:00). The primary endpoint is the occurrence of any first major CVD events after randomisation. We expect to complete the participant recruitment over the first two years and finalise the analysis after an average follow-up of 5 years. Results: We are finalising the project protocol and have applied the proposed project to relevant research grants. An ethics application has also been prepared. We plan to run a one -year pilot trial and then transfer to the full study. Conclusion: The outcomes of this study will contribute to Level 1 evidence on the effect of night-time BP-lowering drug treatment in the prevention of cardiovascular disease in diabetes. Due to the nature of pragmatic design, our research outcomes are straightforward and could be adopted in current practice without any further cost. Changing the ingestion time of BP-lowering drug treatment from morning to night-time is very cost-effective and promises to reduce the financial and clinical burden of CVD and DM on the healthcare system.