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NCT05745090
N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) in Type 2 Diabetes Mellitus
Conditions: Type2diabetes, Heart Failure, Cardiovascular Complication
Sex: All
Ages: 40 Years – 99 Years
Enrollment: 1200
Sponsor: Singapore General Hospital
Location: Singapore
Summary
More than 400 million people have type 2 diabetes (T2D) globally, and the burden of diabetes-related cardiovascular complications is increasing.
Cardiovascular disease (CVD) affects approximately one-third of all individuals with T2D and accounts for half of all deaths in this population despite major advances in the treatment of the disease.
Among the different types of CVD, heart failure (HF) is frequently the first CVD manifestation in individuals with T2D.
Although the link between T2D and CVD is widely recognised, the absolute risk of cardiovascular events varies among individuals with T2D.
As such, effective risk-stratification tool that accurately identify T2D patients at the highest risk of developing incident or recurrent cardiovascular (CV) events is needed.B-type natriuretic peptide (BNP) and its inactive N-terminal precursor NT-proBNP are biomarkers of myocardial stress.
They been shown to incrementally improve predictive discrimination of death and CV events in high-risk individuals with T2D.An NT-proBNP-based CVD/HF risk stratification strategy has not been prospectively tested in the multi-ethnic T2D population in Singapore.
In this study, we aim to:Evaluate the predictive value of NT-proBNP for death and CV events compared to traditional risk markers [e.g.
HbA1c, albuminuria, high sensitivity C-reactive protein (hsCRP), high sensitivity troponin-T (hsTnT)] in a cohort of T2D patients with or without established CVD (defined as ischaemic heart disease, myocardial infarct, unstable angina, prior coronary artery revascularisation, stroke, transient ischaemic attack or PAD) attending a tertiary diabetes care centre.
(Patients with history of HF will be excluded.)Compare the performance of NT-proBNP as a single biomarker for CV risk prediction to risk scoring algorithms in T2D patients.
Eligibility Criteria
Inclusion Criteria:Type 2 diabetes (T2D) of at least 6 months' durationAge 40 and olderExclusion Criteria:Known history of heart failure (self-reported and medical records review)Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2
[using the CKD-Epidemiology Collaboration (CKD-EPI) 2021 equation for glomerular filtration rate] based on the last known eGFR within 12 months of study recruitment)Renal replacement therapySystemic treatment with corticosteroids or immunosuppressantsPregnant or nursing womenActive cancer diseaseSerious disease with life expectancy <1 year as judged by the doctorAny condition that, in the investigator's opinion, would interfere with a subject's ability to comply with study protocol or procedures
Source: ClinicalTrials.gov (NCT05745090). StuddyBuddy aggregates publicly available trial information.