Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes

Recruiting

• Conditions: Type 2 Diabetes; Chronic Heart Failure

• Registration Number: NCT04941794
• Lead Sponsor: Regionshospital Nordjylland

Brief Summary

A cohort study on patients with type 2 diabetes to investigate possible biomarkers as predictors of chronic heart failure.

Detailed Description

A cohort study on 500 patients with type 2 diabetes without known heart disease and age \> 50 years of age. On inclusion and on yearly basis, patients are evaluated by echocardiography, ECG, blood tests to examine NT-ProBNP, hs-CRP, troponin, kidney function and 6 minutes hall walk test.

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-28
• Study Start: 2021-07-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Type 2 diabetes
• age > 50 years

Exclusion Criteria

• History of acute or chronic heart failure
• History of ischemic heart disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chronic Heart Failure	During 5 year follow up	Determined by echocardiography according to European Society of Cardiology (ESC) definitions

Secondary Outcome Measures

Name	Time	Method
NT-ProBNP	During 5 year follow up	Change in N-terminal prohormone of brain natriuretic peptide (NT-ProBNP)
hs-CRP	During 5 year follow up	Change in High-sensitivity C-reactive protein (hs-CRP)
Troponin	During 5 year follow up	Change in Troponin
6 minutes walk test	During 5 year follow up	Change in 6 minutes walk test

Trial Locations

Locations (1)

North Denmark Regional Hospital; 🇩🇰 Hjørring, Denmark