Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)

Novo Nordisk

Status: Invitation-only

Conditions: Chronic Kidney Disease; Heart Failure; Cardiovascular Risk

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT06122961

NN6018-7527

U1111-1286-3420 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 21,504 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

21,504 participants in 4 patient groups

Atherosclerotic cardiovascular disease (ASCVD) with chronic kidney disease (CKD)

Description:

electronic case report form (eGFR) below 60 ml/min/1.73m\^2

Treatment:

Other: No treatment given

ASCVD without CKD

Description:

eGFR greater than or equal to 60 ml/min/1.73m\^2

Treatment:

Other: No treatment given

HF with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF)

Treatment:

Other: No treatment given

Heart failure (HF) with reduced ejection fraction (HFrEF)

Treatment:

Other: No treatment given