Levels of Inflammation in Middle East People With Cardiovascular Disease With/Without Kidney Disease

Launched by NOVO NORDISK A/S · Oct 21, 2024

Keywords

ClinConnect Summary

This is an observational study that aims to find out how common systemic inflammation is in adults from the Middle East who have heart-related diseases, with or without kidney disease. Researchers will take a single study visit to collect background medical information and a blood test to measure inflammation levels. The main question is how many participants have a high inflammation level, defined as hsCRP of 2 mg/L or higher.

Who can participate and what to expect: about 756 adults (18 years or older) with either ASCVD plus chronic kidney disease or heart failure (including HF with preserved or mildly reduced ejection fraction) may be enrolled. Participants will continue their usual care and will not receive any new treatment as part of the study. It’s a snapshot study across multiple sites in Saudi Arabia and the United Arab Emirates. Eligibility includes giving informed consent, not currently in another interventional trial, no recent hospitalization or active infection, and no language barriers that would prevent participation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• • 2. Male or female, age above or equal to 18 years at the time of signing informed consent.
• • 3. Diagnosed with ASCVD+CKD and/or HF (pEF or mrEF)
• Exclusion Criteria:
• • 1. Previous participation in this study. Participation is defined as having given informed consent in this study.
• • 2. Current participation (i.e., signed informed consent) in any other interventional clinical study.
• • 3. Any hospitalization or unplanned visit within the last 60 days (including exacerbation of chronic disease with hospitalization).
• • 4. Clinical evidence, or suspicion of, active infection within the last 60 days.
• • 5. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.