Type 2 DiabetesNCT04941794
Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes and Chronic Heart Failure, run by Regionshospital Nordjylland at 1 site in Denmark.
Trial summary
A cohort study on patients with type 2 diabetes to investigate possible biomarkers as predictors of chronic heart failure. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Chronic Heart Failure
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2021to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 500 patients with known type 2 diabetes who are treated at the department of endocrinology, North Denmark Regional Hospital.
Who may be able to join
- Type 2 diabetes
- age > 50 years
Who cannot join
- History of acute or chronic heart failure
- History of ischemic heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
North Denmark Regional Hospital
Hjørring, 9800
Steen Hyldgaard, MD, s.joergensen@rn.dk
About this study
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.
- Conditions
- Type 2 Diabetes, Chronic Heart Failure
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Heart Failure
Determined by echocardiography according to European Society of Cardiology (ESC) definitions
Measured: During 5 year follow up
Secondary outcomes (4)
NT-ProBNP
Change in N-terminal prohormone of brain natriuretic peptide (NT-ProBNP)
Measured: During 5 year follow up
hs-CRP
Change in High-sensitivity C-reactive protein (hs-CRP)
Measured: During 5 year follow up
Troponin
Change in Troponin
Measured: During 5 year follow up
6 minutes walk test
Change in 6 minutes walk test
Measured: During 5 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Jul 2021
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Steen Hylgaard Jørgensen, MD, Principal investigator, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941794
- Sponsor's protocol ID
- N-20210021
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04941794
- Acronym / sponsor ID
- N-20210021
- Conditions
- Type 2 Diabetes, Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 500 patients with known type 2 diabetes who are treated at the department of endocrinology, North Denmark Regional Hospital.
Key inclusion criteria (2 listed)
- Type 2 diabetes
- age > 50 years
Key exclusion criteria (2 listed)
- History of acute or chronic heart failure
- History of ischemic heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic Heart Failure
Time frame: During 5 year follow up
Determined by echocardiography according to European Society of Cardiology (ESC) definitions
4 secondary outcomes
NT-ProBNP
Time frame: During 5 year follow up
hs-CRP
Time frame: During 5 year follow up
Troponin
Time frame: During 5 year follow up
6 minutes walk test
Time frame: During 5 year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steen Hylgaard Jørgensen, MD principal investigator
Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Chronic Heart Failure, run by Regionshospital Nordjylland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Leutscher, Professor (0045 9764 2652, p.leutscher@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Heart Failure (time frame: During 5 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.