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Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06122961
Collaborator
(none)
21,504
Enrollment
15.1
Anticipated Duration (Months)

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
  • Other: No treatment given

Study Design

Study Type:
Observational
Anticipated Enrollment :
21504 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Prevalence of Systemic Inflammation in Patients With Atherosclerotic Cardiovascular Disease and Heart Failure
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Feb 17, 2025
Anticipated Study Completion Date :
Feb 17, 2025

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

  1. 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

  1. Interleukin 6 (IL-6) [At visit (day 0)]

    pg/ml

  2. N-terminal prohormone of brain natriuretic peptide (NT-proBNP) [At visit (day 0)]

    pg/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:

  1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.

  2. Age 18 years or above at the time of signing the informed consent.

  3. Presence of ASCVD (atherosclerotic cardiovascular disease) and/or HF (heart failure)

  4. Presence of serum creatinine in the medical chart within 24 months prior to signing of informed consent (for ASCVD patients only).

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

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.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT06122961
Other Study ID Numbers:
  • NN6018-7527
  • U1111-1286-3420
First Posted:
Nov 8, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Heart Failure
Cardiovascular Diseases
Inflammation

Study Results

No Results Posted as of Nov 8, 2023