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Recruiting NCT04941794

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

Observational Type 2 Diabetes Chronic Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Chronic Heart Failure. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Chronic Heart Failure [Time frame: During 5 year follow up]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • Type 2 diabetes
  • age > 50 years

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • North Denmark Regional Hospital — Hjørring

Identifiers

NCT: NCT04941794 · N-20210021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗