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RecruitingNCT04941794Updated Mar 10, 2026

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

An observational study in Type 2 Diabetes and Chronic Heart Failure, sponsored by Regionshospital Nordjylland. Recruiting at 1 site in Denmark. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Regionshospital Nordjylland · Observational

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
50 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Type 2 Diabetes
  • Chronic Heart Failure
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 500 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Regionshospital Nordjylland is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type 2 diabetes
  • age > 50 years

Exclusion criteria

Exclusion Criteria:

  • History of acute or chronic heart failure
  • History of ischemic heart disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Chronic Heart Failure

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

    Time frame: During 5 year follow up

Secondary outcomes

  1. NT-ProBNP

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

    Time frame: During 5 year follow up

  2. hs-CRP

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

    Time frame: During 5 year follow up

  3. Troponin

    Change in Troponin

    Time frame: During 5 year follow up

  4. 6 minutes walk test

    Change in 6 minutes walk test

    Time frame: During 5 year follow up

Other outcomes

  1. HOMA-IR

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

    Time frame: During 5 year follow-up

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Jul 2027, 72 months after the start.

Of 432 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 96. This study's planned 72 months is above that.

Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2021
First posted
Jun 28, 2021
StartActual
Jul 1, 2021
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Mar 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04941794
Lead sponsor
Regionshospital Nordjylland
Responsible party
Sponsor
First posted
Jun 28, 2021
Start date
Jul 1, 2021
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Mar 10, 2026

Study contacts

Peter Leutscher, Professor
Contact
p.leutscher@rn.dk
0045 9764 2652
Isabelle Larsen, RN
Contact
isml@rn.dk
0045 2041 6541
Steen Hylgaard Jørgensen, MD
principal investigator · Department of Cardiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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