Study on the Predictive Value of High-sensitivity Cardiac Troponin I, N-terminal Pro-B-natriuretic Peptide, and Soluble Suppression of Tumorigenesis-2 for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV)

Prospective Observational Study on the Predictive Value of Cardiac Damage Markers High-sensitivity Cardiac Troponin I (Hs-cTnI), N-terminal Pro-B-natriuretic Peptide (NT-proBNP) and Soluble Suppression of Tumorigenesis-2 (sST2) for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06902857

Acronym

Diabetes-CV

Enrollment

964

Registered

2025-03-30

Start date

2024-04-18

Completion date

2028-12-31

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Complication, Type 2 Diabetes

Keywords

type 2 diabetes, high-sensitivity cardiac troponin I, N-terminal pro-B-natriuretic peptide, soluble suppression of tumorigenesis-2, mortality risk, diabetes complications

Brief summary

The Diabetes-CV study is an observational study designed to assess the prognostic value of serum cardiac damage markers high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro-B-natriuretic peptide (NT-proBNP), and soluble suppression of tumorigenesis-2 (sST2) in predicting mortality, major adverse cardiovascular events, and diabetic complications in patients with type 2 diabetes.

Detailed description

This single-center, investigator-initiated, prospective observational study aims to evaluate the prognostic value of serum cardiac damage markers such as high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro-B-natriuretic peptide (NT-proBNP) and soluble suppression of tumorigenesis-2 (sST2) in subjects with type 2 diabetes. The study will utilize clinical and laboratory data from patients attending the Diabetology Unit at the IRCCS INRCA Hospital in Ancona (Italy), including both study-specific data and information extracted from routine outpatient medical records.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Inclusion criteria

* type 2 diabetes * patients attending the outpatient services

Exclusion criteria

* type 1 diabetes * patients with active cancer or cancer in remission for less than 5 years * any medical or other reason that leads the investigator to consider the subject ineligible for the study.

Design outcomes

Primary

Measure	Time frame	Description
The occurrence of all-cause mortality	From date of enrollment up to 36 months	Death from any cause

Secondary

Measure	Time frame	Description
Change in high-sensitivity cardiac troponin I levels	At enrollment and 36 months later	The levels of high-sensitivity cardiac troponin I will be analyzed.
The occurence of cardiovascular events	From date of enrollment up to 36 months	Non-fatal cardiovascular events
The Incidence of new diabetic complications	From date of enrollment up to 36 months	The onset of new micro and macrovascular complications of diabetes will be recorded
Change in soluble suppression of tumorigenesis-2 levels	From date of enrollment up to 36 months	The levels of soluble suppression of tumorigenesis-2 will be analyzed.
Change in N-terminal pro-B-natriuretic peptide levels	From date of enrollment up to 36 months	The levels of N-terminal pro-B-natriuretic peptide will be analyzed.

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORElena Tortato, MD

IRCCS INRCA, Ancona, Italy

Outcome results