Prediction of incident heart failure in type 2 diabetes mellitus: Rationale and design of the DM-HEART study

Preclinical heart failure (HF) (stages A and B) is common but easily overlooked in asymptomatic patients with type 2 diabetes (T2D). There is a paucity of evidence regarding how coexisting risk factors contribute to the development of HF in asymptomatic Asian patients with T2D, and there is a lack of guidance on the early identification of asymptomatic patients to help cost-effectively allocate preventive therapies. The Diabetes Mellitus Heart Failure Events Analysis and Risk Tracking (DM-HEART) trial, a prospective, multicenter, longitudinal cohort study, recruited asymptomatic patients with T2D and no prior HF between January 2021 and June 2024, with a minimum follow-up period of 12 months. The primary outcome was incident HF, defined as new-onset HF (requiring either hospitalization or an urgent care visit). Secondary outcomes are measured as 3-point major adverse cardiovascular events, comprised of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. DM-HEART will provide epidemiological data on the incidence of HF and assess the prognostic utility of clinical parameters, including N-terminal pro-B-type natriuretic peptide (NT-proBNP), for predicting incident HF events among asymptomatic patients with T2D in preclinical stages of HF. Furthermore, we aim to determine the optimal NT-proBNP cut-off value for predicting incident HF events in East Asian patients with diabetes.