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

• Conditions: Systemic Inflammation (hsCRP)

• Registration Number: NCT06655493
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Study Start: 2024-12-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 756

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High Sensitivity C-Reactive Protein (hsCRP) ≥2 mg/L	At Visit (day 0)	Count of patients

Trial Locations

Locations (20)

Almoosa Specialist Hospital; 🇸🇦 Al Ahsa, Saudi Arabia

King Fahad Armed Forces, Jeddah; 🇸🇦 Jeddah, Saudi Arabia

King Faisal Specialist Hospital & Research Centre, Jeddah; 🇸🇦 Jeddah, Saudi Arabia

Dr. Sulaiman Al Habib Medical Group- Olaya; 🇸🇦 Riyadh, Saudi Arabia

King Khaled University Hospital,King Saud Univ. Med. City; 🇸🇦 Riyadh, Saudi Arabia

Dallah Hospital_Riyadh; 🇸🇦 Riyadh, Saudi Arabia

King Faisal Specialist Hospital & Research Centre, Riyadh; 🇸🇦 Riyadh, Saudi Arabia

SMC, Riyadh; 🇸🇦 Riyadh, Saudi Arabia

King Fahad Medical City; 🇸🇦 Riyadh, Saudi Arabia

King Salman North Western Armed Force Hospital (NWAFH); 🇸🇦 Tabuk, Saudi Arabia

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