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

March 6, 2026 updated by: Regionshospital Nordjylland
A cohort study on patients with type 2 diabetes to investigate possible biomarkers as predictors of chronic heart failure.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Peter Leutscher, Professor
  • Phone Number: 0045 9764 2652
  • Email: p.leutscher@rn.dk

Study Contact Backup

  • Name: Isabelle Larsen, RN
  • Phone Number: 0045 2041 6541
  • Email: isml@rn.dk

Study Locations

  • Denmark
      • Hjørring, Denmark, 9800
        • Recruiting
        • North Denmark Regional Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

500 patients with known type 2 diabetes who are treated at the department of endocrinology, North Denmark Regional Hospital.

Description

Inclusion Criteria:

  • Type 2 diabetes
  • age > 50 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOMA-IR
Time Frame: During 5 year follow-up
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
During 5 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regionshospital Nordjylland

Investigators

  • Principal Investigator: Steen Hylgaard Jørgensen, MD, Department of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20210021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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