A pilot randomized controlled trial of Tirzepatide in people living with type-2 diabetes and stage B heart failure (360G-Wellcome-343286_Z_25_Z)

The 2015 national diabetes audit identified heart failure (HF) as the most common and deadliest cardiovascular complication of T2DM. HF continues to have high morbidity and mortality, representing an urgent unmet clinical need. Consequently, early detection, prevention and treatment of HF in T2DM is a priority of the NHS and major international cardiology and diabetes societies. Those with T2DM are now classified as at risk or Stage A HF, and those with asymptomatic structural and/or functional cardiac alterations as Stage B HF (SBHF). We hypothesise that a 24-week treatment of Tirzepatide in those with SBHF will lead to significant weight loss and reverse remodelling of cardiac structural and functional changes. We anticipate clinically meaningful improvements in cardiac outcomes (LV mass and GLS), exploratory markers (NT- proBNP and hsCRP), functional capacity (Peak Vo2) and quality of life (EQ-5D-5L). Thus, building evidence for the use of Tirzepatide as part of an early preventive treatment for HF in those with T2DM. Additionally, we will assess whether a 6-month delay in treatment affects outcomes by initiating Tirzepatide in the control arm after 24 weeks. Finally, to support sustained weight loss for significant reverse remodelling, treatment in the intervention group will continue until week 52.