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Type2diabetesPISCESNCT05745090

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

An observational study of Type2diabetes and Heart Failure, run by Singapore General Hospital at 1 site in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 99 years
How many people
1,200 participants
Where
1 siteSingapore
Study dates
10 Nov 2022to 30 Apr 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Type 2 diabetes mellitus age 40 and above, without known history of heart failure.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Singapore General Hospital

    Singapore

Other trials in Singapore

About this study

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

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.

Read more

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.
Read the detailed description

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.

Keywords
Diabetes, Risk prediction
Medical subject headings
Heart Failure, Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 5 years

Secondary outcomes (5)

  1. 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.

    Measured: 5 years

  2. Number of participants with all-cause death

    Death due to any cause.

    Measured: 5 years

  3. 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.

    Measured: 5 years

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

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

    Measured: 5 years

  5. Number of participants with all-cause hospitalization

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2023
  2. Study start10 Nov 2022
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05745090
Sponsor's protocol ID
PISCES2022
Acronym
PISCES
Status last verified
Apr 2024
First submitted
9 Feb 2023
Last updated
22 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared

Publications

  • Matheus AS, Tannus LR, Cobas RA, Palma CC, Negrato CA, Gomes MB. Impact of diabetes on cardiovascular disease: an update. Int J Hypertens. 2013;2013:653789. doi: 10.1155/2013/653789. Epub 2013 Mar 4.

    PubMed 23533715

  • Birkeland KI, Bodegard J, Eriksson JW, Norhammar A, Haller H, Linssen GCM, Banerjee A, Thuresson M, Okami S, Garal-Pantaler E, Overbeek J, Mamza JB, Zhang R, Yajima T, Komuro I, Kadowaki T. Heart failure and chronic kidney disease manifestation and mortality risk associations in type 2 diabetes: A large multinational cohort study. Diabetes Obes Metab. 2020 Sep;22(9):1607-1618. doi: 10.1111/dom.14074. Epub 2020 Jun 3.

    PubMed 32363737

  • Hobbs FD, Jukema JW, Da Silva PM, McCormack T, Catapano AL. Barriers to cardiovascular disease risk scoring and primary prevention in Europe. QJM. 2010 Oct;103(10):727-39. doi: 10.1093/qjmed/hcq122. Epub 2010 Aug 4.

    PubMed 20685842

  • Malachias MVB, Jhund PS, Claggett BL, Wijkman MO, Bentley-Lewis R, Chaturvedi N, Desai AS, Haffner SM, Parving HH, Prescott MF, Solomon SD, De Zeeuw D, McMurray JJV, Pfeffer MA. NT-proBNP by Itself Predicts Death and Cardiovascular Events in High-Risk Patients With Type 2 Diabetes Mellitus. J Am Heart Assoc. 2020 Oct 20;9(19):e017462. doi: 10.1161/JAHA.120.017462. Epub 2020 Sep 23.

    PubMed 32964800

Questions about this trial

What is this clinical trial studying?

An observational study of Type2diabetes and Heart Failure, run by Singapore General Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with composite endpoint based on first occurrence of all-cause death or cardiovascular events (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05745090, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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