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NCT Number: NCT04941794

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

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

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Key information

Conditions

Type 2 Diabetes Chronic Heart Failure Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Denmark Regional Hospital

Hjørring, 9800, Denmark

Location status: Recruiting

Location contact

Steen Hyldgaard, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Type 2 diabetes
  • age > 50 years

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Chronic Heart Failure

    Time frame: During 5 year follow up

    Determined by echocardiography according to European Society of Cardiology (ESC) definitions

Secondary outcomes

  1. NT-ProBNP

    Time frame: During 5 year follow up

    Change in N-terminal prohormone of brain natriuretic peptide (NT-ProBNP)

  2. hs-CRP

    Time frame: During 5 year follow up

    Change in High-sensitivity C-reactive protein (hs-CRP)

  3. Troponin

    Time frame: During 5 year follow up

    Change in Troponin

  4. 6 minutes walk test

    Time frame: During 5 year follow up

    Change in 6 minutes walk test

Other outcomes

  1. HOMA-IR

    Time frame: During 5 year follow-up

    Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle Larsen, RN

CONTACT

[email protected]

0045 2041 6541

Peter Leutscher, Professor

CONTACT

[email protected]

0045 9764 2652

Sponsors and collaborators

Lead sponsor

Regionshospital Nordjylland

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 28, 2021
Registry last updated
Mar 10, 2026

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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