Biomarkers as Predictors of Chronic Heart Failure in Pati... | NCT04941794

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

NCT04941794

Sponsor

Regionshospital Nordjylland

Status

Recruiting

Last Update Posted

Mar 10, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Type 2 Diabetes
Chronic Heart Failure

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Jul 2027Estimated

Completion Date

Jul 2027Estimated

First Submitted Date

Jun 21, 2021

First Submission Date that Met QC Criteria

Jun 21, 2021

First Posted Date

Jun 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2026

Last Update Posted Date

Mar 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes
age > 50 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Leutscher, Professor	Contact	0045 9764 2652		p.leutscher@rn.dk
Isabelle Larsen, RN	Contact	0045 2041 6541		isml@rn.dk

Overall Officials

Name	Affiliation	Role
Steen Hylgaard Jørgensen, MD	Department of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Denmark Regional Hospital	Recruiting	Hjørring		9800	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided