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

NCT ID: NCT06655493

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

756 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-22

Study Completion Date

2025-08-28

Brief Summary

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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

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Conditions

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Systemic Inflammation (hsCRP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ASCVD with CKD

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

No treatment given

Intervention Type OTHER

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)

No treatment given

Intervention Type OTHER

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

Interventions

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No treatment given

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Almoosa Specialist Hospital

Al Ahsa, , Saudi Arabia

Site Status

King Fahad Armed Forces, Jeddah

Jeddah, , Saudi Arabia

Site Status

King Faisal Specialist Hospital & Research Centre, Jeddah

Jeddah, , Saudi Arabia

Site Status

Dr. Sulaiman Al Habib Medical Group- Olaya

Riyadh, , Saudi Arabia

Site Status

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

Riyadh, , Saudi Arabia

Site Status

Dallah Hospital_Riyadh

Riyadh, , Saudi Arabia

Site Status

King Faisal Specialist Hospital & Research Centre, Riyadh

Riyadh, , Saudi Arabia

Site Status

SMC, Riyadh

Riyadh, , Saudi Arabia

Site Status

King Fahad Medical City

Riyadh, , Saudi Arabia

Site Status

King Salman North Western Armed Force Hospital (NWAFH)

Tabuk, , Saudi Arabia

Site Status

Cleveland Clinic Abu Dhabi

Abu Dhabhi, , United Arab Emirates

Site Status

Tawam Hospital (SEHA)

Abu Dhabhi, , United Arab Emirates

Site Status

Mediclinic Abu Dhabi

Abu Dhabhi, , United Arab Emirates

Site Status

Imperial college, Abu Dhabi

Abu Dhabhi, , United Arab Emirates

Site Status

Fujairah Hospital

Al Fujairah City, , United Arab Emirates

Site Status

Sheikh Khalifa Hospital Fujairah

Al Fujairah City, , United Arab Emirates

Site Status

Tadwai hospital

Dubai, , United Arab Emirates

Site Status

Rashid Hospital

Dubai, , United Arab Emirates

Site Status

Dubai Hospital

Dubai, , United Arab Emirates

Site Status

Al Qassimi Hospital, Sharjah

Sharjah city, , United Arab Emirates

Site Status

Countries

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Saudi Arabia United Arab Emirates

Other Identifiers

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U1111-1303-1767

Identifier Type: OTHER

Identifier Source: secondary_id

DAS-8043

Identifier Type: -

Identifier Source: org_study_id

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