NCT05745090Active, not recruiting
N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) in Type 2 Diabetes Mellitus
Performance of NT-proBNP in Risk Stratification for Cardiovascular Events and Mortality in Patients With Diabetes (PISCES)
Source: ClinicalTrials.gov · Last updated 22 Apr 2024
Brief summary (registry, in English)
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: 1. 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.) 2. Compare the performance of NT-proBNP as a single biomarker for CV risk prediction to risk scoring algorithms in T2D patients.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 9 Feb 2023
- Start date
- 10 Nov 2022
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Singapore General Hospital
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT05745090
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 10 Nov 2022 to the primary completion date, 31 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Renal replacement therapy
- Systemic treatment with corticosteroids or immunosuppressants
Other illness
- Known history of heart failure (self-reported and medical records review)
- Active cancer disease
- Serious disease with life expectancy \<1 year as judged by the doctor
- Any condition that, in the investigator's opinion, would interfere with a subject's ability to comply with study protocol or procedures
Lab values
- 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)
Other
- Pregnant or nursing women
Who the study is looking for
- Type 2 diabetes (T2D) of at least 6 months' duration
- Age 40 and older
Age in the registry: 40 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Singapore General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.