High Dose RAS-Antagonist and Beta-Blocker Treatment to Prevent Cardiac Events in Adults with Type 2 Diabetes Without Heart Disease

What this Trial Is About

Researchers are evaluating the effect of high dose Renin-Angiotensin System RAS-antagonists and beta-blocker treatments for preventing cardiac events in patients with Type 2 diabetes mellitus T2DM who have no signs of existing heart disease. The study aims to show if these treatments reduce unplanned hospitalizations or death from cardiac events compared to standard therapy, especially in patients with higher levels of the biomarker NT-proBNP. There is also a related eye sub-study to assess the impact of these treatments on early diabetic eye complications and how NT-proBNP levels may affect diabetic retinopathy progression. Participants are randomly assigned to two groups. One group receives high doses of RAS-antagonists and beta-blockers up to maximum tolerated levels, added to their usual diabetes treatment. The other group receives standard diabetes care and may continue stable doses of these drugs but without dose increases during the study. The study involves up-titration visits for the treatment group to safely adjust medication doses. The eye sub-study enrolls a subset of patients for specialized eye exams every six months over two years. Participants attend scheduled visits at screening, 3 months, 12 months, and 24 months after starting treatment. Assessments include blood tests for safety and biomarkers, vital signs, and documentation of medications. The treatment group uses diaries to record blood pressure, heart rate, and symptoms during dose adjustments. Long-term follow-up through registries or phone calls monitors mortality and hospitalizations. The main outcome measured is the number of patients experiencing unplanned cardiac hospitalizations or cardiac-related death over two years.

NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients