Clinical trial NCT06655493: Levels of Inflammation in Middle East People With Cardiovascular Disease With/Without Kidney Disease
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Systemic Inflammation (hsCRP)
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: High Sensitivity C-Reactive Protein (hsCRP) ≥2 mg/L
timeFrame: At Visit (day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ahsa
country: Saudi Arabia
facility: Almoosa Specialist Hospital
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces, Jeddah
city: Jeddah
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre, Jeddah
city: Riyadh
country: Saudi Arabia
facility: Dr. Sulaiman Al Habib Medical Group- Olaya
city: Riyadh
country: Saudi Arabia
facility: King Khaled University Hospital,King Saud Univ. Med. City
city: Riyadh
country: Saudi Arabia
facility: Dallah Hospital_Riyadh
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre, Riyadh
city: Riyadh
country: Saudi Arabia
facility: SMC, Riyadh
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Tabuk
country: Saudi Arabia
facility: King Salman North Western Armed Force Hospital (NWAFH)
city: Abu Dhabhi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi
city: Abu Dhabhi
country: United Arab Emirates
facility: Tawam Hospital (SEHA)
city: Abu Dhabhi
country: United Arab Emirates
facility: Mediclinic Abu Dhabi
city: Abu Dhabhi
country: United Arab Emirates
facility: Imperial college, Abu Dhabi
city: Dubai
country: United Arab Emirates
facility: Tadwai hospital
city: Dubai
country: United Arab Emirates
facility: Rashid Hospital
city: Dubai
country: United Arab Emirates
facility: Dubai Hospital
city: Fujairah
country: United Arab Emirates
facility: Fujairah Hospital
city: Fujairah
country: United Arab Emirates
facility: Sheikh Khalifa Hospital Fujairah
city: Sharjah
country: United Arab Emirates
facility: Al Qassimi Hospital, Sharjah
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: