Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)

Heart Failure Clinical Trial

— POSEIDON  

Official title:

Prevalence of Systemic Inflammation in Patients With Atherosclerotic Cardiovascular Disease and Heart Failure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06122961
• Other study ID #: NN6018-7527
• Secondary ID: U1111-1286-3420
• Status: Enrolling by invitation
• Start date: November 15, 2023
• Est. completion date: February 17, 2025

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 21504
• Est. completion date: February 17, 2025
• Est. primary completion date: February 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk
• Chronic Kidney Disease
• Heart Failure
• Inflammation
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• No treatment given
No treatment given

Locations

Country	Name	City	State
Argentina	Instituto Médico DAMIC	Córdoba
Brazil	Nucleo de Pesquisa Clinica do Hospital Vera Cruz	Belo Horizonte/MG
Canada	Corcare Cardiovascular Research Inc	Scarborough	Ontario
Canada	CardioVasc HR Inc	St. Jean sur Richelieu	Quebec
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
Germany	Al-Zoebi	Wermsdorf
Korea, Republic of	Seoul National University Hospital	Seoul
Poland	Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman	Gdynia
United States	Mission Cardiovascular Research Institute	Fremont	California
United States	Texas Institute of Cardiology PA	McKinney	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  China,  Germany,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L (yes/ no)	Count of patient	At visit (day 0)
Secondary	Interleukin 6 (IL-6)	pg/ml	At visit (day 0)
Secondary	N-terminal prohormone of brain natriuretic peptide (NT-proBNP)	pg/ml	At visit (day 0)