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Clinical Trials/NCT06655493
NCT06655493
Completed
Not Applicable

A Cross-sectional Study to Investigate Prevalence of Systemic Inflammation (hsCRP) in Cohort of Patients With HF and a Cohort of Patients With ASCVD and CKD in the Middle East

Novo Nordisk A/S20 sites in 2 countries756 target enrollmentNovember 22, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systemic Inflammation (hsCRP)
Sponsor
Novo Nordisk A/S
Enrollment
756
Locations
20
Primary Endpoint
High Sensitivity C-Reactive Protein (hsCRP) ≥2 mg/L
Status
Completed
Last Updated
6 months ago

Overview

Brief Summary

This study will collect medical and background information from participants with diseases that affect the heart and blood vessels (cardiovascular disease) with/without kidney disease.

The aim of the study is to assess the number of people with high levels of systemic inflammation among Middle East people with cardiovascular with/without kidney disease. Systemic inflammation means that it occurs throughout the body.

Participation in this study only requires a single visit at the clinic/hospital/medical institution. Participants will continue their normal care and will not get any treatment as part of this study.

Registry
clinicaltrials.gov
Start Date
November 22, 2024
End Date
August 28, 2025
Last Updated
6 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • Male or female, age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with ASCVD+CKD and/or HF (pEF or mrEF)

Exclusion Criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Current participation (i.e., signed informed consent) in any other interventional clinical study.
  • Any hospitalization or unplanned visit within the last 60 days (including exacerbation of chronic disease with hospitalization).
  • Clinical evidence, or suspicion of, active infection within the last 60 days.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Outcomes

Primary Outcomes

High Sensitivity C-Reactive Protein (hsCRP) ≥2 mg/L

Time Frame: At Visit (day 0)

Count of patients

Study Sites (20)

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