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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06122961




Registration number
NCT06122961
Ethics application status
Date submitted
3/11/2023
Date registered
8/11/2023

Titles & IDs
Public title
Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)
Scientific title
Prevalence of Systemic Inflammation in Patients With Atherosclerotic Cardiovascular Disease and Heart Failure
Secondary ID [1] 0 0
U1111-1286-3420
Secondary ID [2] 0 0
NN6018-7527
Universal Trial Number (UTN)
Trial acronym
POSEIDON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Risk 0 0
Heart Failure 0 0
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No treatment given

Atherosclerotic cardiovascular disease (ASCVD) with chronic kidney disease (CKD) - electronic case report form (eGFR) below 60 ml/min/1.73m\^2

ASCVD without CKD - eGFR greater than or equal to 60 ml/min/1.73m\^2

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

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


Other interventions: No treatment given
No treatment given
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
High sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L (yes/ no)
Timepoint [1] 0 0
At visit (day 0)
Secondary outcome [1] 0 0
Interleukin 6 (IL-6)
Timepoint [1] 0 0
At visit (day 0)
Secondary outcome [2] 0 0
N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Timepoint [2] 0 0
At visit (day 0)

Eligibility
Key inclusion criteria
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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/02/2025
Actual
Sample size
Target
21504
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Renal Research Gosford - Gosford
Recruitment hospital [2] 0 0
Advara HeartCare - Auchenflower
Recruitment hospital [3] 0 0
Advara HeartCare - Leabrook
Recruitment hospital [4] 0 0
Barwon Health (The Geelong Hospital) - Geelong
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
5068 - Leabrook
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires, Argentina
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Santa Fe
Country [6] 0 0
Argentina
State/province [6] 0 0
Córdoba
Country [7] 0 0
Argentina
State/province [7] 0 0
Mendoza
Country [8] 0 0
Brazil
State/province [8] 0 0
Paraná
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio Grande Do Sul
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
Brazil
State/province [11] 0 0
Belo Horizonte/MG
Country [12] 0 0
Brazil
State/province [12] 0 0
Brasília
Country [13] 0 0
Brazil
State/province [13] 0 0
Campinas
Country [14] 0 0
Brazil
State/province [14] 0 0
Goiânia
Country [15] 0 0
Brazil
State/province [15] 0 0
Marília/SP
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio de Janeiro
Country [17] 0 0
Brazil
State/province [17] 0 0
Salvador
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Jose Rio Preto
Country [19] 0 0
Brazil
State/province [19] 0 0
São Bernardo
Country [20] 0 0
Brazil
State/province [20] 0 0
São Paulo
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Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
China
State/province [24] 0 0
Beijing
Country [25] 0 0
China
State/province [25] 0 0
Gansu
Country [26] 0 0
China
State/province [26] 0 0
Guangdong
Country [27] 0 0
China
State/province [27] 0 0
Hainan
Country [28] 0 0
China
State/province [28] 0 0
Hunan
Country [29] 0 0
China
State/province [29] 0 0
Jiangsu
Country [30] 0 0
China
State/province [30] 0 0
Jilin
Country [31] 0 0
China
State/province [31] 0 0
Liaoning
Country [32] 0 0
China
State/province [32] 0 0
Jinan
Country [33] 0 0
Czechia
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Praha 1
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Denmark
State/province [34] 0 0
Region Sjælland
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Denmark
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Frederiksberg
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Denmark
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Herlev
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Denmark
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Herning
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Denmark
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Hillerød
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Hvidovre
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Denmark
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København S
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Denmark
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København ø
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Denmark
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Roskilde
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France
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Amiens Cedex 1
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France
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Bordeaux
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France
State/province [45] 0 0
Bron
Country [46] 0 0
France
State/province [46] 0 0
Chambray Les Tours
Country [47] 0 0
France
State/province [47] 0 0
Compiegne
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France
State/province [48] 0 0
Dijon
Country [49] 0 0
France
State/province [49] 0 0
Grenoble cedex 9
Country [50] 0 0
France
State/province [50] 0 0
Le Chesnay-Rocquencourt
Country [51] 0 0
France
State/province [51] 0 0
Le Coudray
Country [52] 0 0
France
State/province [52] 0 0
Limoges
Country [53] 0 0
France
State/province [53] 0 0
Lyon
Country [54] 0 0
France
State/province [54] 0 0
Montauban
Country [55] 0 0
France
State/province [55] 0 0
Montpellier Cedex 5
Country [56] 0 0
France
State/province [56] 0 0
Nice
Country [57] 0 0
France
State/province [57] 0 0
Nimes Cedex 9
Country [58] 0 0
France
State/province [58] 0 0
ORLEANS Cedex 2
Country [59] 0 0
France
State/province [59] 0 0
Paris
Country [60] 0 0
France
State/province [60] 0 0
Pau
Country [61] 0 0
France
State/province [61] 0 0
Poitiers
Country [62] 0 0
France
State/province [62] 0 0
Rennes
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France
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Rouen
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France
State/province [64] 0 0
Saint Herblain
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France
State/province [65] 0 0
Saint Ouen Sur Seine
Country [66] 0 0
France
State/province [66] 0 0
Toulon
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France
State/province [67] 0 0
Toulouse Cedex 9
Country [68] 0 0
France
State/province [68] 0 0
Vandoeuvre Les Nancy
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Germany
State/province [69] 0 0
Baden-Württemberg
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Germany
State/province [70] 0 0
EK Uni Lübeck
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Germany
State/province [71] 0 0
Berlin
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Germany
State/province [72] 0 0
Bonn
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Germany
State/province [73] 0 0
Bremen
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Germany
State/province [74] 0 0
Dortmund
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Germany
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Dresden
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Germany
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Düsseldorf
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Germany
State/province [77] 0 0
Elsterwerda
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Germany
State/province [78] 0 0
Essen
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Germany
State/province [79] 0 0
Frankfurt am Main
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Germany
State/province [80] 0 0
Friedrichshafen
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Germany
State/province [81] 0 0
Göttingen
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Germany
State/province [82] 0 0
Homburg/Saar
Country [83] 0 0
Germany
State/province [83] 0 0
Jena
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Germany
State/province [84] 0 0
Kaiserslautern
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Germany
State/province [85] 0 0
Mainz
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Germany
State/province [86] 0 0
Mannheim
Country [87] 0 0
Germany
State/province [87] 0 0
München
Country [88] 0 0
Germany
State/province [88] 0 0
Tübingen
Country [89] 0 0
Germany
State/province [89] 0 0
Warendorf
Country [90] 0 0
Germany
State/province [90] 0 0
Wermsdorf
Country [91] 0 0
Germany
State/province [91] 0 0
Würzburg
Country [92] 0 0
India
State/province [92] 0 0
Jammu And Kashmir
Country [93] 0 0
India
State/province [93] 0 0
Madhya Pradesh
Country [94] 0 0
India
State/province [94] 0 0
Maharashtra
Country [95] 0 0
India
State/province [95] 0 0
Punjab
Country [96] 0 0
India
State/province [96] 0 0
Tamil Nadu
Country [97] 0 0
India
State/province [97] 0 0
Uttarakhand
Country [98] 0 0
India
State/province [98] 0 0
West Bengal
Country [99] 0 0
Italy
State/province [99] 0 0
Catanzaro
Country [100] 0 0
Italy
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Genova
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Italy
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Milano
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Italy
State/province [102] 0 0
Milan
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Italy
State/province [103] 0 0
Torino
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Italy
State/province [104] 0 0
Venezia
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Italy
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Bergamo
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Italy
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Brescia
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Italy
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Caserta
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Italy
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Cosenza
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Italy
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Napoli
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Italy
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Pisa
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Ragusa
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Reggio Emilia
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Roma
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Sassari
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Siena
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Italy
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Udine
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Korea, Republic of
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Timis
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gangwon-do
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
State/province [128] 0 0
Seoul
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Norway
State/province [129] 0 0
Bodø
Country [130] 0 0
Norway
State/province [130] 0 0
Grålum
Country [131] 0 0
Norway
State/province [131] 0 0
Oslo
Country [132] 0 0
Norway
State/province [132] 0 0
Skedsmokorset
Country [133] 0 0
Poland
State/province [133] 0 0
Gdynia
Country [134] 0 0
Poland
State/province [134] 0 0
Katowice
Country [135] 0 0
Poland
State/province [135] 0 0
Lodz
Country [136] 0 0
Poland
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Oswiecim
Country [137] 0 0
Poland
State/province [137] 0 0
Sopot
Country [138] 0 0
Poland
State/province [138] 0 0
Szczecin
Country [139] 0 0
Poland
State/province [139] 0 0
Tychy
Country [140] 0 0
Poland
State/province [140] 0 0
Wroclaw
Country [141] 0 0
Sweden
State/province [141] 0 0
Lund
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Crawley

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06122961