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NCT Number: NCT05745090

N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) in Type 2 Diabetes Mellitus

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type2diabetes Cardiovascular Complication Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore General Hospital

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes (T2D) of at least 6 months' duration
  • Age 40 and older

Exclusion 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 therapy
  • Systemic treatment with corticosteroids or immunosuppressants
  • Pregnant or nursing women
  • 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

Treatment and study plan

Primary outcomes

  1. Number of participants with composite endpoint based on first occurrence of all-cause death or cardiovascular events

    Time frame: 5 years

    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).

Secondary outcomes

  1. Number of participants with cardiovascular (CV) death

    Time frame: 5 years

    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.

  2. Number of participants with all-cause death

    Time frame: 5 years

    Death due to any cause.

  3. Number of unplanned hospitalization for heart failure (HHF)

    Time frame: 5 years

    Refers to heart failure event that was a cause of hospitalization (primary or contributing) following baseline visit.

  4. Number of participants with 4-point major adverse cardiovascular event (MACE)

    Time frame: 5 years

    Include CV death, non-fatal myocardial infarction, non-fatal stroke, unplanned HHF

  5. Number of participants with all-cause hospitalization

    Time frame: 5 years

    Include emergency, unplanned or non-elective all-cause hospitalizations

Other outcomes

  1. Proportion of study subjects with reduced left ventricular systolic function

    Time frame: Baseline

    Proportion of study subjects with reduced left ventricular systolic function

  2. Proportion of study subjects with reduced left ventricular diastolic function

    Time frame: Baseline

    Proportion of study subjects with reduced left ventricular diastolic function

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Official study title

Performance of NT-proBNP in Risk Stratification for Cardiovascular Events and Mortality in Patients With Diabetes (PISCES)

Acronym: PISCES

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Feb 27, 2023
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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