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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
Date last updated
28/10/2024

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
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Argentina
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Buenos Aires, Argentina
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
Country [6] 0 0
Argentina
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Córdoba
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Argentina
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Mendoza
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Brazil
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Paraná
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Brazil
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Belo Horizonte/MG
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Brazil
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Brasília
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Brazil
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Campinas
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Brazil
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Goiânia
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Brazil
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Marília/SP
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Sao Jose Rio Preto
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Brazil
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São Bernardo
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Brazil
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São Paulo
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Gansu
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China
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Guangdong
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China
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Hainan
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China
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Hunan
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China
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Jiangsu
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China
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Jilin
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China
State/province [31] 0 0
Liaoning
Country [32] 0 0
China
State/province [32] 0 0
Harbin
Country [33] 0 0
China
State/province [33] 0 0
Jinan
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China
State/province [34] 0 0
Xi'an
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Czechia
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Praha 1
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Denmark
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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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Denmark
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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
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Bron
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France
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Chambray Les Tours
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France
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Compiegne
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France
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Dijon
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France
State/province [51] 0 0
Grenoble cedex 9
Country [52] 0 0
France
State/province [52] 0 0
Le Chesnay-Rocquencourt
Country [53] 0 0
France
State/province [53] 0 0
Le Coudray
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France
State/province [54] 0 0
Limoges
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France
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Lyon
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France
State/province [56] 0 0
Montauban
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France
State/province [57] 0 0
Montpellier Cedex 5
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France
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Nice
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France
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Nimes Cedex 9
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France
State/province [60] 0 0
ORLEANS Cedex 2
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France
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Paris
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France
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Pau
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France
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Poitiers
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France
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Rennes
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France
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Rouen
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France
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Saint Herblain
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France
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Saint Ouen Sur Seine
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France
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Toulon
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France
State/province [69] 0 0
Toulouse Cedex 9
Country [70] 0 0
France
State/province [70] 0 0
Vandoeuvre Les Nancy
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Germany
State/province [71] 0 0
Baden-Württemberg
Country [72] 0 0
Germany
State/province [72] 0 0
EK Uni Lübeck
Country [73] 0 0
Germany
State/province [73] 0 0
Berlin
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Germany
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Bonn
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Germany
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Bremen
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Germany
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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
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Elsterwerda
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Germany
State/province [80] 0 0
Essen
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Germany
State/province [81] 0 0
Frankfurt am Main
Country [82] 0 0
Germany
State/province [82] 0 0
Friedrichshafen
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Germany
State/province [83] 0 0
Göttingen
Country [84] 0 0
Germany
State/province [84] 0 0
Homburg/Saar
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Germany
State/province [85] 0 0
Jena
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Germany
State/province [86] 0 0
Kaiserslautern
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Germany
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Mainz
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Germany
State/province [88] 0 0
Mannheim
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Germany
State/province [89] 0 0
München
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Germany
State/province [90] 0 0
Tübingen
Country [91] 0 0
Germany
State/province [91] 0 0
Warendorf
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Germany
State/province [92] 0 0
Wermsdorf
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Germany
State/province [93] 0 0
Würzburg
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India
State/province [94] 0 0
Jammu And Kashmir
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India
State/province [95] 0 0
Madhya Pradesh
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India
State/province [96] 0 0
Maharashtra
Country [97] 0 0
India
State/province [97] 0 0
Punjab
Country [98] 0 0
India
State/province [98] 0 0
Tamil Nadu
Country [99] 0 0
India
State/province [99] 0 0
Uttarakhand
Country [100] 0 0
India
State/province [100] 0 0
West Bengal
Country [101] 0 0
Italy
State/province [101] 0 0
Catanzaro
Country [102] 0 0
Italy
State/province [102] 0 0
Genova
Country [103] 0 0
Italy
State/province [103] 0 0
Milano
Country [104] 0 0
Italy
State/province [104] 0 0
Milan
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Italy
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Torino
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Italy
State/province [106] 0 0
Venezia
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Italy
State/province [107] 0 0
Bergamo
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Italy
State/province [108] 0 0
Brescia
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Italy
State/province [109] 0 0
Caserta
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Italy
State/province [110] 0 0
Cosenza
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Italy
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Napoli
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Italy
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Palermo
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Ragusa
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Sassari
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Italy
State/province [120] 0 0
Siena
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Italy
State/province [121] 0 0
Udine
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Korea, Republic of
State/province [122] 0 0
Timis
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Busan
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Korea, Republic of
State/province [124] 0 0
Daegu
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Daejeon
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Korea, Republic of
State/province [126] 0 0
Gangwon-do
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Gwangju
Country [128] 0 0
Korea, Republic of
State/province [128] 0 0
Gyeonggi-do
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Gyeonggi-Do
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Seoul
Country [131] 0 0
Norway
State/province [131] 0 0
Bodø
Country [132] 0 0
Norway
State/province [132] 0 0
Grålum
Country [133] 0 0
Norway
State/province [133] 0 0
Oslo
Country [134] 0 0
Norway
State/province [134] 0 0
Skedsmokorset
Country [135] 0 0
Poland
State/province [135] 0 0
Gdynia
Country [136] 0 0
Poland
State/province [136] 0 0
Katowice
Country [137] 0 0
Poland
State/province [137] 0 0
Lodz
Country [138] 0 0
Poland
State/province [138] 0 0
Oswiecim
Country [139] 0 0
Poland
State/province [139] 0 0
Sopot
Country [140] 0 0
Poland
State/province [140] 0 0
Szczecin
Country [141] 0 0
Poland
State/province [141] 0 0
Tychy
Country [142] 0 0
Poland
State/province [142] 0 0
Wroclaw
Country [143] 0 0
Sweden
State/province [143] 0 0
Jönköping
Country [144] 0 0
Sweden
State/province [144] 0 0
Karlstad
Country [145] 0 0
Sweden
State/province [145] 0 0
Lund
Country [146] 0 0
Sweden
State/province [146] 0 0
Stockholm
Country [147] 0 0
Sweden
State/province [147] 0 0
Uppsala
Country [148] 0 0
Sweden
State/province [148] 0 0
Örebro
Country [149] 0 0
United Kingdom
State/province [149] 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
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.
Trial website
https://clinicaltrials.gov/study/NCT06122961
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06122961