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

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Inflammation (hsCRP)
• Intervention / Treatment: Other: No treatment given

• Study Type: Observational
• Enrollment (Actual): 756

Contacts and Locations

Study Locations

• Saudi Arabia
  • Al Ahsa, Saudi Arabia, 36342
    • Almoosa Specialist Hospital
  • Jeddah, Saudi Arabia, 23311
    • King Fahad Armed Forces, Jeddah
  • Jeddah, Saudi Arabia, 23433
    • King Faisal Specialist Hospital & Research Centre, Jeddah
  • Riyadh, Saudi Arabia, 59046
    • King Fahad Medical City
  • Riyadh, Saudi Arabia, 12372
    • King Khaled University Hospital,King Saud Univ. Med. City
  • Riyadh, Saudi Arabia, 12713
    • King Faisal Specialist Hospital & Research Centre, Riyadh
  • Riyadh, Saudi Arabia, 12214
    • Dr. Sulaiman Al Habib Medical Group- Olaya
  • Riyadh, Saudi Arabia, 13215
    • SMC, Riyadh
  • Riyadh, Saudi Arabia, 12381
    • Dallah Hospital_Riyadh
  • Tabuk, Saudi Arabia, 47512
    • King Salman North Western Armed Force Hospital (NWAFH)
• United Arab Emirates
  • Abu Dhabhi, United Arab Emirates, 112412
    • Cleveland Clinic Abu Dhabi
  • Abu Dhabhi, United Arab Emirates, 15258
    • Tawam Hospital (SEHA)
  • Abu Dhabhi, United Arab Emirates, 46713
    • Mediclinic Abu Dhabi
  • Abu Dhabhi, United Arab Emirates, 48338
    • Imperial college, Abu Dhabi
  • Al Fujairah City, United Arab Emirates, 12345
    • Fujairah Hospital
  • Al Fujairah City, United Arab Emirates, 12345
    • Sheikh Khalifa Hospital Fujairah
  • Dubai, United Arab Emirates, 4545
    • Rashid Hospital
  • Dubai, United Arab Emirates, 7272
    • Dubai Hospital
  • Dubai, United Arab Emirates, 123456
    • Tadwai hospital
  • Sharjah city, United Arab Emirates, 12345
    • Al Qassimi Hospital, Sharjah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A cohort of patients with HF and a cohort of patients with ASCVD and CKD in the Middle East

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ASCVD with CKD; Study participants diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD) with Chronic Kidney Disease (CKD)	Other: No treatment given; Participants will continue their normal care and will not get any treatment as part of this study.
HFpEF or HFmrEF; Study participants diagnosed with Heart Failure (HF) with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF)	Other: No treatment given; Participants will continue their normal care and will not get any treatment as part of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Sensitivity C-Reactive Protein (hsCRP) ≥2 mg/L	Count of patients	At Visit (day 0)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2024
• Primary Completion (Actual): August 28, 2025
• Study Completion (Actual): August 28, 2025

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: DAS-8043; U1111-1303-1767 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No