NCT04941794

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jul 2021Jul 2027

First Submitted

Initial submission to the registry

June 21, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

June 21, 2021

Last Update Submit

March 6, 2026

Conditions

Type 2 DiabetesChronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Chronic Heart Failure

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

    During 5 year follow up

Secondary Outcomes (4)

  • NT-ProBNP

    During 5 year follow up

  • hs-CRP

    During 5 year follow up

  • Troponin

    During 5 year follow up

  • 6 minutes walk test

    During 5 year follow up

Other Outcomes (1)

  • HOMA-IR

    During 5 year follow-up

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Type 2 diabetes
  • age \> 50 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Denmark Regional Hospital

Hjørring, 9800, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Steen Hylgaard Jørgensen, MD

    Department of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Leutscher, Professor

CONTACT

0045 9764 2652p.leutscher@rn.dk

Isabelle Larsen, RN

CONTACT

0045 2041 6541isml@rn.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 28, 2021

Study Start

July 1, 2021

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

DK(1)