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NCT04941794 Clinical Trial

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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04941794
Other study ID # RHN_SHJ_01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date July 2027

Study information
Verified date August 2021
Source Vendsyssel Hospital
Contact Peter Leutscher, Professor
Phone 0045 9764 2652
Email p.leutscher@rn.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date July 2027
Est. primary completion date July 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Type 2 diabetes - age > 50 years Exclusion Criteria: - History of acute or chronic heart failure - History of ischemic heart disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark North Denmark Regional Hospital Hjørring

Sponsors (1)
Lead Sponsor Collaborator
Vendsyssel Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other HOMA-IR Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During 5 year follow-up
Primary Chronic Heart Failure Determined by echocardiography according to European Society of Cardiology (ESC) definitions During 5 year follow up
Secondary NT-ProBNP Change in N-terminal prohormone of brain natriuretic peptide (NT-ProBNP) During 5 year follow up
Secondary hs-CRP Change in High-sensitivity C-reactive protein (hs-CRP) During 5 year follow up
Secondary Troponin Change in Troponin During 5 year follow up
Secondary 6 minutes walk test Change in 6 minutes walk test During 5 year follow up
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