Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)
Study Details
Study Description
Brief Summary
This study will collect medical and background information from participants with diseases that affect the heart and blood vessels (cardiovascular disease). Participants will continue their normal care and will not get any treatment other than those the study doctor has prescribed.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Atherosclerotic cardiovascular disease (ASCVD) with chronic kidney disease (CKD) electronic case report form (eGFR) below 60 ml/min/1.73m^2 |
Other: No treatment given
No treatment given
|
ASCVD without CKD eGFR greater than or equal to 60 ml/min/1.73m^2 |
Other: No treatment given
No treatment given
|
HF with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF)
|
Other: No treatment given
No treatment given
|
Heart failure (HF) with reduced ejection fraction (HFrEF)
|
Other: No treatment given
No treatment given
|
Outcome Measures
Primary Outcome Measures
- High sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L (yes/ no) [At visit (day 0)]
Count of patient
Secondary Outcome Measures
- Interleukin 6 (IL-6) [At visit (day 0)]
pg/ml
- N-terminal prohormone of brain natriuretic peptide (NT-proBNP) [At visit (day 0)]
pg/ml
Eligibility Criteria
Criteria
Inclusion criteria:
-
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.
-
Age 18 years or above at the time of signing the informed consent.
-
Presence of ASCVD (atherosclerotic cardiovascular disease) and/or HF (heart failure)
-
Presence of serum creatinine in the medical chart within 24 months prior to signing of informed consent (for ASCVD patients only).
Exclusion criteria:
-
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN6018-7527
- U1111-1286-3420