Systemic Inflammation (hsCRP)INFLAMEASTNCT06655493
Levels of Inflammation in Middle East People With Cardiovascular Disease With/Without Kidney Disease
An observational study of Systemic Inflammation (hsCRP), run by Novo Nordisk A/S at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammation (hsCRP)
- What is being tested?
- No treatment given
- How many people
- 756 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 22 Nov 2024to 28 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of patients with HF and a cohort of patients with ASCVD and CKD in the Middle East
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Saudi Arabia10 sites
Almoosa Specialist Hospital
Al Ahsa, 36342
King Fahad Armed Forces, Jeddah
Jeddah, 23311
King Faisal Specialist Hospital & Research Centre, Jeddah
Jeddah, 23433
Dr. Sulaiman Al Habib Medical Group- Olaya
Riyadh, 12214
King Khaled University Hospital,King Saud Univ. Med. City
Riyadh, 12372
Dallah Hospital_Riyadh
Riyadh, 12381
King Faisal Specialist Hospital & Research Centre, Riyadh
Riyadh, 12713
SMC, Riyadh
Riyadh, 13215
King Fahad Medical City
Riyadh, 59046
King Salman North Western Armed Force Hospital (NWAFH)
Tabuk, 47512
United Arab Emirates10 sites
Cleveland Clinic Abu Dhabi
Abu Dhabhi, 112412
Tawam Hospital (SEHA)
Abu Dhabhi, 15258
Mediclinic Abu Dhabi
Abu Dhabhi, 46713
Imperial college, Abu Dhabi
Abu Dhabhi, 48338
Tadwai hospital
Dubai, 123456
Rashid Hospital
Dubai, 4545
Dubai Hospital
Dubai, 7272
Fujairah Hospital
Fujairah, 12345
Sheikh Khalifa Hospital Fujairah
Fujairah, 12345
Al Qassimi Hospital, Sharjah
Sharjah city, 12345
About this study
Official title: 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.
- Conditions
- Systemic Inflammation (hsCRP)
- Being tested
- No treatment given
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
Participants will continue their normal care and will not get any treatment as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| ASCVD with CKD | Study participants diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD) with Chronic Kidney Disease (CKD) Receives: 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) Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Sensitivity C-Reactive Protein (hsCRP) ≥2 mg/L
Count of patients
Measured: At Visit (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start22 Nov 2024
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammation (hsCRP)Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655493
- Sponsor's protocol ID
- DAS-8043
- Other IDs
- U1111-1303-1767
- Acronym
- INFLAMEAST
- Status last verified
- Oct 2025
- First submitted
- 21 Oct 2024
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06655493
- Acronym / sponsor ID
- INFLAMEAST / DAS-8043
- Conditions
- Systemic Inflammation (hsCRP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASCVD with CKD | – | Other: No treatment givenStudy participants diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD) with Chronic Kidney Disease (CKD) |
| HFpEF or HFmrEF | – | Other: No treatment givenStudy participants diagnosed with Heart Failure (HF) with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of patients with HF and a cohort of patients with ASCVD and CKD in the Middle East
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenParticipants will continue their normal care and will not get any treatment as part of this study. | Other | ASCVD with CKD, HFpEF or HFmrEF |
Primary outcome
High Sensitivity C-Reactive Protein (hsCRP) ≥2 mg/L
Time frame: At Visit (day 0)
Count of patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Inflammation (hsCRP), run by Novo Nordisk A/S at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Saudi Arabia, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Sensitivity C-Reactive Protein (hsCRP) ≥2 mg/L (time frame: At Visit (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.