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

NCT06655493 | Completed

• 2 other identifiers: DAS-8043U1111-1303-1767
• Study Type: observational
• Target: 756
• Locations: 2 countries
• Sites: 20

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.

Conditions

Systemic Inflammation (hsCRP)

Outcome Measures

Primary Outcomes (1)

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

  Count of patients

  At Visit (day 0)

Study Arms (2)

ASCVD with CKD

Study participants diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD) with Chronic Kidney Disease (CKD)

Other: No treatment given

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

Interventions

No treatment given OTHER

Participants will continue their normal care and will not get any treatment as part of this study.

ASCVD with CKD; HFpEF or HFmrEF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (20)

Almoosa Specialist Hospital

Al Ahsa, 36342, Saudi Arabia

Location

King Fahad Armed Forces, Jeddah

Jeddah, 23311, Saudi Arabia

Location

King Faisal Specialist Hospital & Research Centre, Jeddah

Jeddah, 23433, Saudi Arabia

Location

Dr. Sulaiman Al Habib Medical Group- Olaya

Riyadh, 12214, Saudi Arabia

Location

King Khaled University Hospital,King Saud Univ. Med. City

Riyadh, 12372, Saudi Arabia

Location

Dallah Hospital_Riyadh

Riyadh, 12381, Saudi Arabia

Location

King Faisal Specialist Hospital & Research Centre, Riyadh

Riyadh, 12713, Saudi Arabia

Location

SMC, Riyadh

Riyadh, 13215, Saudi Arabia

Location

King Fahad Medical City

Riyadh, 59046, Saudi Arabia

Location

King Salman North Western Armed Force Hospital (NWAFH)

Tabuk, 47512, Saudi Arabia

Location

Cleveland Clinic Abu Dhabi

Abu Dhabhi, 112412, United Arab Emirates

Location

Tawam Hospital (SEHA)

Abu Dhabhi, 15258, United Arab Emirates

Location

Mediclinic Abu Dhabi

Abu Dhabhi, 46713, United Arab Emirates

Location

Imperial college, Abu Dhabi

Abu Dhabhi, 48338, United Arab Emirates

Location

Tadwai hospital

Dubai, 123456, United Arab Emirates

Location

Rashid Hospital

Dubai, 4545, United Arab Emirates

Location

Dubai Hospital

Dubai, 7272, United Arab Emirates

Location

Fujairah Hospital

Fujairah, 12345, United Arab Emirates

Location

Sheikh Khalifa Hospital Fujairah

Fujairah, 12345, United Arab Emirates

Location

Al Qassimi Hospital, Sharjah

Sharjah city, 12345, United Arab Emirates

Location

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: November 22, 2024
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

SA (10); AE (10)