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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04941794

Enrollment

500

Registered

2021-06-28

Start date

2021-07-01

Completion date

2027-07-01

Last updated

2026-03-10

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

Conditions

Chronic Heart Failure, Type 2 Diabetes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Type 2 diabetes * age \> 50 years

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Denmark

Contacts

CONTACTPeter Leutscher, Professor

p.leutscher@rn.dk0045 9764 2652

CONTACTIsabelle Larsen, RN

isml@rn.dk0045 2041 6541

PRINCIPAL_INVESTIGATORSteen Hylgaard Jørgensen, MD

Department of Cardiology

Outcome results