An observational study in Type2diabetes, Heart Failure and Cardiovascular Complication, sponsored by Singapore General Hospital. Active, not recruiting at 1 site in Singapore. Open to participants aged 40 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Singapore General Hospital · Observational
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:
This is a prospective single-site, observational study to evaluate the predictive value of NT-proBNP for death and CV events compared to traditional CV risk markers (e.g., HbA1c, albuminuria, hsCRP and hsTnT) in 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). Patients with history of HF will be excluded. The study will also compare the performance of NT-proBNP as a single biomarker for CV risk prediction to other risk scoring algorithms such as UK Prospective Diabetes Study (UKPDS) risk engine, Risk Equations for Complications Of Type 2 Diabetes (RECODe) and University of Hong Kong-Singapore (HKU-SG) risk scores.
The study will prospectively recruit 1200 adults (aged 40 and above) with T2D from Singapore General Hospital (SGH) over a period of 18 months. Informed consent will be obtained from patients before the start of any procedures. There will be 1 baseline visit to collect demographic information, and clinical and laboratory data. Baseline point-of-care echocardiography will also be performed for all patients. All patients will subsequently be observed over 5 years for the occurrence of death or CV events through monitoring of electronic health records (EHR) and telephone contacts.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Type 2 diabetes mellitus age 40 and above, without known history of heart failure.
Exclusion Criteria:
Number of participants with composite endpoint based on first occurrence of all-cause death or cardiovascular events
Composite endpoint based on the first occurrence of all-cause death or CV events consisting of a composite of non-fatal myocardial infarction, non-fatal stroke, unplanned hospitalisation for heart failure (HHF), coronary revascularisation (PCI or CABG), non-traumatic lower limb amputation, or lower limb arterial revascularisation (surgical or endovascular).
Time frame: 5 years
Number of participants with cardiovascular (CV) death
Cardiovascular death consists of death due to acute myocardial infarction, sudden cardiac death, death due to heart failure, stroke, CV procedure, CV hemorrhage or other CV cause.
Time frame: 5 years
Number of participants with all-cause death
Death due to any cause.
Time frame: 5 years
Number of unplanned hospitalization for heart failure (HHF)
Refers to heart failure event that was a cause of hospitalization (primary or contributing) following baseline visit.
Time frame: 5 years
Number of participants with 4-point major adverse cardiovascular event (MACE)
Include CV death, non-fatal myocardial infarction, non-fatal stroke, unplanned HHF
Time frame: 5 years
Number of participants with all-cause hospitalization
Include emergency, unplanned or non-elective all-cause hospitalizations
Time frame: 5 years
Proportion of study subjects with reduced left ventricular systolic function
Proportion of study subjects with reduced left ventricular systolic function
Time frame: Baseline
Proportion of study subjects with reduced left ventricular diastolic function
Proportion of study subjects with reduced left ventricular diastolic function
Time frame: Baseline
Plan to share: No — No individual participant data will be shared
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Singapore General Hospital