Clinical trial NCT06122961: Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)
Official title: Prevalence of Systemic Inflammation in Patients With Atherosclerotic Cardiovascular Disease and Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk
Heart Failure
Chronic Kidney Disease
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 18198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from cardiology sites reflecting a real-world population of ASCVD and HF patients.

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.


Eligibility 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).

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

Primary outcomes:
measure: High sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L (yes/ no)
timeFrame: At visit (day 0)
Secondary outcomes:
measure: Interleukin 6 (IL-6)
timeFrame: At visit (day 0)
measure: N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
timeFrame: At visit (day 0)
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Mission Cardiovascular Research Institute
state: California
city: McKinney
country: United States
facility: Texas Institute of Cardiology PA
state: Texas
city: Caba
country: Argentina
facility: Fundacion Favaloro
state: Buenos Aires, Argentina
city: Bahia Blanca
country: Argentina
facility: Hospital Italiano Regional Sur
state: Buenos Aires
city: Coronel Suarez
country: Argentina
facility: Clínica Coronel Suarez
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Italiano de la Plata
state: Buenos Aires
city: Lanus Este
country: Argentina
facility: Centro Médico CIMEL
state: Buenos Aires
city: Rosario
country: Argentina
facility: INECO Neurociencias Oroño
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: DIM Clinica Privada
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes SRL
city: Córdoba
country: Argentina
facility: Instituto Médico DAMIC
city: Mendoza
country: Argentina
facility: Hospital Luis Lagomaggiore
city: Gosford
country: Australia
facility: Renal Research Gosford
state: New South Wales
city: Auchenflower
country: Australia
facility: Advara HeartCare
state: Queensland
city: Leabrook
country: Australia
facility: Advara HeartCare
state: South Australia
city: Geelong
country: Australia
facility: Barwon Health (The Geelong Hospital)
state: Victoria
city: Campina Grande do Sul
country: Brazil
facility: Sociedade Hospitalar Angelina Caron, Brazil
state: Paraná
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: i9 Pesquisas Clínicas
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
state: Sao Paulo
city: Belo Horizonte/MG
country: Brazil
facility: Nucleo de Pesquisa Clinica do Hospital Vera Cruz
city: Brasília
country: Brazil
facility: Hospital do Coração do Brasil
city: Campinas
country: Brazil
facility: IPECC - Instituto de Pesquisa Clínica de Campinas
city: Goiânia
country: Brazil
facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
city: Marília/SP
country: Brazil
facility: ICM - Instituto do Coração de Marília
city: Rio de Janeiro
country: Brazil
facility: Instituto D'OR de Pesquisa e Ensino
city: Salvador
country: Brazil
facility: Hospital Ana Nery
city: Sao Jose Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
city: São Bernardo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos
city: São Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP
city: New West Minster
country: Canada
facility: Fraser Clinical Trials Inc.
state: British Columbia
city: North Vancouver
country: Canada
facility: North Shore Heart Centre
state: British Columbia
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Centre
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Cardiology Clinical Trials
state: Ontario
city: Scarborough
country: Canada
facility: Corcare Cardiovascular Research Inc
state: Ontario
city: Scarborough
country: Canada
facility: Corcare Cardiovascular Research
state: Ontario
city: Winchester
country: Canada
facility: Winchester Dist Memorial Hosp
state: Ontario
city: Brossard
country: Canada
facility: [Legal] Viacar Recherches Cliniques, Inc.
state: Quebec
city: St. Jean sur Richelieu
country: Canada
facility: CardioVasc HR Inc
state: Quebec
city: Trois-Rivières
country: Canada
facility: CIUSSS de la Mauricie-et-du-Centre-du-Québec
state: Quebec
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Lanzhou
country: China
facility: NIS-Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University-Cardiology
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
city: Jinan
country: China
facility: The Second Hospital of Shandong University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University-Cardiovascular
city: Praha 1
country: Czechia
facility: Nemocnice Na Františku
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
state: Region Sjælland
city: Frederiksberg
country: Denmark
facility: Bispebjerg og Frederiksberg Hospital
city: Herlev
country: Denmark
facility: Herlev og Gentofte Hospital
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup, Hjertesygdomme
city: Hillerød
country: Denmark
facility: Hillerød Endokrinologisk amb. H0652
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital Hjertemedicinsk
city: København S
country: Denmark
facility: Amager Hospital - Medicinsk Amb
city: København ø
country: Denmark
facility: Rigshospitalet
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital_Roskilde
city: Amiens Cedex 1
country: France
facility: Centre Hospitalier Universitaire Amiens Picardie-Site Sud
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
city: Bron
country: France
facility: Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-1
city: Chambray Les Tours
country: France
facility: Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau
city: Compiegne
country: France
facility: Centre Hospitalier Intercommunal Compiegne - Noyon
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage
city: Grenoble cedex 9
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1
city: Le Chesnay-Rocquencourt
country: France
facility: Centre Hospitalier de Versailles-Hopital Andre Mignot
city: Le Coudray
country: France
facility: Les Hopitaux de Chartres-Hopital Louis Pasteur
city: Limoges
country: France
facility: Centre Hospitalier Et Universitaire de Limoges-Hopital Dupuytren
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
city: Montauban
country: France
facility: Clinique Pont de Chaume
city: Montpellier Cedex 5
country: France
facility: Centre Hospitalier Universitaire de Montpellier-Hopital Saint-Eloi
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice-Hopital Pasteur
city: Nimes Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Nimes-Hopital Caremeau
city: ORLEANS Cedex 2
country: France
facility: Centre Hospitalier Universitaire D'Orleans
city: Paris
country: France
facility: Ap-Hp-Hopital Hotel Dieu Paris
city: Paris
country: France
facility: Ap-Hp-Hopital Cochin
city: Pau
country: France
facility: Centre Hospitalier de Pau - Hopital Francois Mitterrand
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
city: Saint Ouen Sur Seine
country: France
facility: Aura Paris
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
city: Vandoeuvre Les Nancy
country: France
facility: Chru de Nancy - Hopital Brabois
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg Herzzentrum
state: Baden-Württemberg
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad - Langensteinbach GmbH - Innere Medizin
state: Baden-Württemberg
city: Lübeck
country: Germany
facility: Med. Universität Lübeck
state: EK Uni Lübeck
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin - Klinik für Kardiologie, Angiologie und Intensivmedizin
city: Berlin
country: Germany
facility: Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn (AöR) - Medizinische Klinik und Poliklinik II - Herzzentrum
city: Bremen
country: Germany
facility: Kardiologisch-Angiologische Praxis Herzzentrum Bremen
city: Dortmund
country: Germany
facility: Kath. St. Paulus GmbH - Kardiologie
city: Dresden
country: Germany
facility: MVZ "Am Felsenkeller" (Dresden)
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Düsseldorf
country: Germany
facility: DaVita Clinical Research Deutschland GmbH
city: Elsterwerda
country: Germany
facility: Zentrum fuer klinische Studien Suedbrandenburg GmbH
city: Essen
country: Germany
facility: Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt aM - Kardiologie
city: Friedrichshafen
country: Germany
facility: Klinikum Friedrichshafen GmbH - Klinik für Kardiologie, Angiologie, Pneumologie und internistische Intensivmedizin
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen - Dept. Herzzentrum Göttingen
city: Homburg/Saar
country: Germany
facility: UKS - Klinik für Pädiatrische Onkologie und Hämatologie
city: Jena
country: Germany
facility: Universitätsklinikum Jena - Kardiologie
city: Kaiserslautern
country: Germany
facility: Kardiopraxis Schirmer
city: Mainz
country: Germany
facility: Marienhaus Klinikum Mainz GmbH - Innere Medizin I
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, Kardiologie I, Studienzentrum
city: Mannheim
country: Germany
facility: zero PRAXEN Mannheim-Schwetzingerstadt
city: München
country: Germany
facility: Klinikum rechts der Isar TU München - Nephrologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen - Innere Medizin III Kardiologie und Angiologie
city: Warendorf
country: Germany
facility: Josephs-Hospital Warendorf - Medizinische Klinik II
city: Wermsdorf
country: Germany
facility: Al-Zoebi
city: Würzburg
country: Germany
facility: Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
city: Srinagar
country: India
facility: Gauri Heart Centre
state: Jammu And Kashmir
city: Bhopal
country: India
facility: Manoria Heart and Critical Care Hospital
state: Madhya Pradesh
city: Nagpur
country: India
facility: Arneja Heart & Multispeciality Hospital
state: Maharashtra
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
state: Punjab
city: Chennai
country: India
facility: The Madras Medical Mission
state: Tamil Nadu
city: Dehradun
country: India
facility: Shri Mahant Indiresh Hospital
state: Uttarakhand
city: Kolkata
country: India
facility: Apollo Multispeciality Hospital, Kolkata
state: West Bengal
city: Germaneto
country: Italy
facility: Policlinico Mater Domini Università di Catanzaro
state: Catanzaro
city: Lavagna
country: Italy
facility: Ospedale del Tigullio ASL4 Liguria
state: Genova
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Sesto San Giovanni
country: Italy
facility: IRCCS Multimedica
state: Milano
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
city: Rivoli
country: Italy
facility: Complesso Ospedaliero "Nuovo Ospedale di Rivoli"
state: Torino
city: Zelarino
country: Italy
facility: Ospedale dell'Angelo
state: Venezia
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
city: Brescia
country: Italy
facility: University of Brescia
city: Caserta
country: Italy
facility: AO S. Anna e S. Sebastiano
city: Cosenza
country: Italy
facility: Presidio Ospedaliero dell'Annunziata
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria San Martino - IST
city: Milano
country: Italy
facility: Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: AORN A. Cardarelli
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II di Napoli
city: Palermo
country: Italy
facility: A.O.U. Policlinico Giaccone
city: Parma
country: Italy
facility: Azienda Ospedaliera-Universitaria Parma
city: Perugia
country: Italy
facility: AOU Perugia
city: Pisa
country: Italy
facility: Fondazione Toscana G. Monastiero
city: Ragusa
country: Italy
facility: ASP Ragusa
city: Reggio Emilia
country: Italy
facility: Arcispedale S Maria Nuova Azienda ULSS-IRCCS
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Fondazione Univ. Policlinico A.Gemelli
city: Sassari
country: Italy
facility: AOU Sassari
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Udine
country: Italy
facility: Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Timis
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic Univ. Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Yonsei University Wonju Severance christian hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Gyeonggi-Do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Bodø
country: Norway
facility: Nordland Hospital Trust
city: Grålum
country: Norway
facility: Sykehuset Østfold Kalnes
city: Oslo
country: Norway
facility: Colosseumklinikken Medisinske Senter AS
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Rikshospitalet
city: Skedsmokorset
country: Norway
facility: Skedsmo Medisinske Senter, Norway
city: Gdynia
country: Poland
facility: Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
state: Pomorskie
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska s.c. Iwona Woźniak Skowerska Mariusz Skowerski
city: Lodz
country: Poland
facility: SPZOZ USK im. Wojskowej Akademii Medycznej UM w Łodzi - Centralny Szpital Weteranów
city: Oswiecim
country: Poland
facility: Medicome Sp. z o.o.
city: Sopot
country: Poland
facility: NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
city: Tychy
country: Poland
facility: Polsko-Amerykanskie Kliniki Serca.American Heart of Poland Sp. z o.o.
city: Wroclaw
country: Poland
facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
city: Danderyd
country: Sweden
facility: Danderyd sjukhus
city: Jönköping
country: Sweden
facility: Medicinkliniken Ryhov
city: Karlstad
country: Sweden
facility: Centralsjukhuset Karlstad
city: Lund
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: Sodersjukhuset AB
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset Uppsala
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
city: Gatwick
country: United Kingdom
facility: Master Centre for United Kingdom
state: West Sussex
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: