AzTrials
AzTrials

Cardiovascular RiskPOSEIDONNCT06122961

Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)

An observational study of Cardiovascular Risk and Heart Failure, run by Novo Nordisk A/S at 195 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
No treatment given
How many people
18,198 participants
Where
195 sitesin 17 countries
Study dates
23 Nov 2023to 30 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants will be recruited from cardiology sites reflecting a real-world population of ASCVD and HF patients.

Who may be able to join

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.
  • Age 18 years or above at the time of signing the informed consent.
  • Presence of ASCVD (atherosclerotic cardiovascular disease) and/or HF (heart failure)
  • Presence of serum creatinine in the medical chart within 24 months prior to signing of informed consent (for ASCVD patients only).

Who cannot join

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Current participation (i.e., signed informed consent) in any other interventional clinical study.
  • Any hospitalization or unplanned visit within the last 60 days (including exacerbation of chronic disease with hospitalization).
  • Clinical evidence, or suspicion of, active infection within the last 60 days.
  • Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation

Trial locations and contacts

195 sites in 17 countries.

195 sites in 17 countries

France27 sites

  • Centre Hospitalier Universitaire Amiens Picardie-Site Sud

    Amiens, 80054

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre

    Bordeaux, 33000

  • Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-1

    Bron, 69500

  • Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau

    Chambray-lès-Tours, 37170

  • Centre Hospitalier Intercommunal Compiegne - Noyon

    Compiègne, 60200

  • Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage

    Dijon, 21000

  • Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1

    Grenoble, 38043

  • Centre Hospitalier de Versailles-Hopital Andre Mignot

    Le Chesnay-Rocquencourt, 78150

  • Les Hopitaux de Chartres-Hopital Louis Pasteur

    Le Coudray, 28630

  • Centre Hospitalier Et Universitaire de Limoges-Hopital Dupuytren

    Limoges, 87000

  • Centre Hospitalier Saint Joseph Saint Luc

    Lyon, 69007

  • Clinique Pont de Chaume

    Montauban, 82000

  • Centre Hospitalier Universitaire de Montpellier-Hopital Saint-Eloi

    Montpellier, 34295

  • Centre Hospitalier Universitaire de Nice-Hopital Pasteur

    Nice, 06000

  • Centre Hospitalier Universitaire de Nimes-Hopital Caremeau

    Nîmes, 30029

  • Centre Hospitalier Universitaire D'Orleans

    Orléans, 45067

  • Ap-Hp-Hopital Hotel Dieu Paris

    Paris, 75004

  • Ap-Hp-Hopital Cochin

    Paris, 75014

  • Centre Hospitalier de Pau - Hopital Francois Mitterrand

    Pau, 64000

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86000

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35000

  • Clinique Saint Hilaire

    Rouen, 76000

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1

    Saint-Herblain, 44800

  • Aura Paris

    Saint-Ouen, 93400

  • Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse

    Toulon, 83100

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1

    Toulouse, 31059

  • Chru de Nancy - Hopital Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Germany27 sites

  • Charité - Campus Benjamin Franklin - Klinik für Kardiologie, Angiologie und Intensivmedizin

    Berlin, 12203

  • Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)

    Berlin, 13353

  • Universitätsklinikum Bonn (AöR) - Medizinische Klinik und Poliklinik II - Herzzentrum

    Bonn, 53127

  • Kardiologisch-Angiologische Praxis Herzzentrum Bremen

    Bremen, 28277

  • Kath. St. Paulus GmbH - Kardiologie

    Dortmund, 44137

  • MVZ "Am Felsenkeller" (Dresden)

    Dresden, 01277

  • Herzzentrum Dresden GmbH Universitätsklinik

    Dresden, 01307

  • DaVita Clinical Research Deutschland GmbH

    Düsseldorf, 40210

  • Zentrum fuer klinische Studien Suedbrandenburg GmbH

    Elsterwerda, 04910

  • Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie

    Essen, 45147

  • Universitätsklinikum Frankfurt aM - Kardiologie

    Frankfurt am Main, 60590

  • Universitätsklinikum Freiburg Herzzentrum

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Klinikum Friedrichshafen GmbH - Klinik für Kardiologie, Angiologie, Pneumologie und internistische Intensivmedizin

    Friedrichshafen, 88048

  • Universitätsmedizin Göttingen - Dept. Herzzentrum Göttingen

    Göttingen, 37075

  • UKS - Klinik für Pädiatrische Onkologie und Hämatologie

    Homburg/Saar, 66424

  • Universitätsklinikum Jena - Kardiologie

    Jena, 07747

  • Kardiopraxis Schirmer

    Kaiserslautern, 67655

  • SRH Klinikum Karlsbad - Langensteinbach GmbH - Innere Medizin

    Karlsbad, Baden-Wurttemberg, 76307

  • Med. Universität Lübeck

    Lübeck, EK Uni Lübeck, 23562

  • Marienhaus Klinikum Mainz GmbH - Innere Medizin I

    Mainz, 55131

  • Universitätsmedizin Mainz, Kardiologie I, Studienzentrum

    Mainz, 55131

  • zero PRAXEN Mannheim-Schwetzingerstadt

    Mannheim, 68165

  • Klinikum rechts der Isar TU München - Nephrologie

    München, 81675

  • Universitätsklinikum Tübingen - Innere Medizin III Kardiologie und Angiologie

    Tübingen, 72076

  • Josephs-Hospital Warendorf - Medizinische Klinik II

    Warendorf, 48231

  • Al-Zoebi

    Wermsdorf, 04779

  • Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz

    Würzburg, 97078

Other trials in Germany

Italy27 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

  • University of Brescia

    Brescia, 25123

  • AO S. Anna e S. Sebastiano

    Caserta, 81100

  • Presidio Ospedaliero dell'Annunziata

    Cosenza, 87100

  • IRCCS Azienda Ospedaliero Universitaria San Martino - IST

    Genova, 16132

  • Policlinico Mater Domini Università di Catanzaro

    Germaneto, Catanzaro, 88100

  • Ospedale del Tigullio ASL4 Liguria

    Lavagna, Genova, 16033

  • Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • AORN A. Cardarelli

    Naples, 80100

  • Azienda Ospedaliera Universitaria Federico II di Napoli

    Naples, 80131

  • A.O.U. Policlinico Giaccone

    Palermo, 90127

  • Azienda Ospedaliera-Universitaria Parma

    Parma, 43126

  • AOU Perugia

    Perugia, 6129

  • Fondazione Toscana G. Monastiero

    Pisa, 56126

  • ASP Ragusa

    Ragusa, 97100

  • Arcispedale S Maria Nuova Azienda ULSS-IRCCS

    Reggio Emilia, 42123

  • Complesso Ospedaliero "Nuovo Ospedale di Rivoli"

    Rivoli, Torino, 10098

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 154

  • Fondazione Univ. Policlinico A.Gemelli

    Roma, 168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • IRCCS Policlinico San Donato

    San Donato Milanese, Milan, 20097

  • AOU Sassari

    Sassari, 7100

  • IRCCS Multimedica

    Sesto San Giovanni, Milano, 20099

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100

  • Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia

    Udine, 33100

  • Ospedale dell'Angelo

    Zelarino, Venezia, 30174

Other trials in Italy

South Korea19 sites

  • Pusan National University Hospital

    Busan, 49241

  • Daegu Catholic Univ. Medical Center

    Daegu, 42472

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • Chungnam National University Hospital

    Daejeon, 35015

  • Chungbuk National University Hospital

    Daejeon, 361-711

  • Yonsei University Wonju Severance christian hospital

    Gangwon-do, 26426

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Hallym University Sacred Heart Hospital

    Gyeonggi-do, 14068

  • Gachon University Gil Medical Center

    Incheon, Timis, 405-220

  • Kyunghee University Medical Center

    Seoul, 02447

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul Saint Mary's Hospital

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

China16 sites

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

  • China-Japan Union Hospital of Jilin University-Cardiology

    Changchun, Jilin, 130033

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu, 213000

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy

    Guangzhou, Guangdong, 510120

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, 150001

  • The Second Hospital of Shandong University

    Jinan, 250033

  • NIS-Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110067

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • The First Affiliated Hospital of Xi'an Jiaotong University-Cardiovascular

    Xi'an, 710061

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

Other trials in China

Brazil14 sites

  • Nucleo de Pesquisa Clinica do Hospital Vera Cruz

    Belo Horizonte/MG, 30220-140

  • Hospital do Coração do Brasil

    Brasília, 70390903

  • Sociedade Hospitalar Angelina Caron, Brazil

    Campina Grande do Sul, Paraná, 83430-000

  • i9 Pesquisas Clínicas

    Campinas, São Paulo, 13092-133

  • IPECC - Instituto de Pesquisa Clínica de Campinas

    Campinas, 13060-080

  • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

    Goiânia, 74605-020

  • ICM - Instituto do Coração de Marília

    Marília/SP, 17515-000

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Instituto D'OR de Pesquisa e Ensino

    Rio de Janeiro, 22281-100

  • Hospital Ana Nery

    Salvador, 40323-010

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo, 09715-090

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    Sao Jose Rio Preto, 15090-000

  • Hospital Alemão Oswaldo Cruz

    São Paulo, São Paulo, 01323-903

  • Universidade Federal de Sao Paulo - UNIFESP

    São Paulo, 99999

Other trials in Brazil

Argentina10 sites

  • Hospital Italiano Regional Sur

    Bahía Blanca, Buenos Aires, B8001HXD

  • DIM Clinica Privada

    Buenos Aires, B1704ETD

  • Instituto de Investigaciones Clinicas Quilmes SRL

    Buenos Aires, B1878GEG

  • Fundacion Favaloro

    CABA, Buenos Aires, Argentina, C1093AAS

  • Instituto Médico DAMIC

    Córdoba, X5003DCE

  • Clínica Coronel Suarez

    Coronel Suárez, Buenos Aires, 7540

  • Hospital Italiano de la Plata

    La Plata, Buenos Aires, B 1900AXI

  • Centro Médico CIMEL

    Lanús Este, Buenos Aires, B1824KAJ

  • Hospital Luis Lagomaggiore

    Mendoza, M5500

  • INECO Neurociencias Oroño

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Canada10 sites

  • [Legal] Viacar Recherches Cliniques, Inc.

    Brossard, Quebec, J4Z2K9

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario, N1R 6V6

  • Fraser Clinical Trials Inc.

    New West Minster, British Columbia, V3L 3W4

  • North Shore Heart Centre

    North Vancouver, British Columbia, V7M 2H4

  • Kawartha Cardiology Clinical Trials

    Peterborough, Ontario, K9J 0B2

  • CardioVasc HR Inc

    Saint-Jean-sur-Richelieu, Quebec, J3A 1J2

  • Corcare Cardiovascular Research Inc

    Scarborough Village, Ontario, M1B 5N1

  • Corcare Cardiovascular Research

    Scarborough Village, Ontario, M1B 5N1

  • CIUSSS de la Mauricie-et-du-Centre-du-Québec

    Trois-Rivières, Quebec, G8Z 3R9

  • Winchester Dist Memorial Hosp

    Winchester, Ontario, K0C 2K0

Other trials in Canada

Denmark9 sites

  • Bispebjerg og Frederiksberg Hospital

    Frederiksberg, 2000

  • Herlev og Gentofte Hospital

    Herlev, 2730

  • Regionshospitalet Gødstrup, Hjertesygdomme

    Herning, 7400

  • Hillerød Endokrinologisk amb. H0652

    Hillerød, 3400

  • Holbæk Sygehus

    Holbæk, Region Sjælland, 4300

  • Hvidovre Hospital Hjertemedicinsk

    Hvidovre, 2650

  • Rigshospitalet

    København Ø, 2100

  • Amager Hospital - Medicinsk Amb

    København S, 2300

  • Sjællands Universitetshospital_Roskilde

    Roskilde, 4000

Other trials in Denmark

Poland8 sites

  • Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman

    Gdynia, Pomeranian Voivodeship, 81-157

  • Specjalistyczna Praktyka Lekarska s.c. Iwona Woźniak Skowerska Mariusz Skowerski

    Katowice, 40-530

  • SPZOZ USK im. Wojskowej Akademii Medycznej UM w Łodzi - Centralny Szpital Weteranów

    Lodz, 90-549

  • Medicome Sp. z o.o.

    Oświęcim, 32-600

  • NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.

    Sopot, 81-852

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.

    Szczecin, 71-434

  • Polsko-Amerykanskie Kliniki Serca.American Heart of Poland Sp. z o.o.

    Tychy, 43-100

  • 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

    Wroclaw, 53-114

Other trials in Poland

Sweden8 sites

  • Danderyd sjukhus

    Danderyd, 182 88

  • Medicinkliniken Ryhov

    Jönköping, 553 05

  • Centralsjukhuset Karlstad

    Karlstad, 652 30

  • Skane University Hospital

    Lund, 22185

  • Universitetssjukhuset Örebro

    Örebro, 701 85

  • Sodersjukhuset AB

    Stockholm, 118 67

  • Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl

    Stockholm, 171 64

  • Akademiska sjukhuset Uppsala

    Uppsala, 75185

Other trials in Sweden

India7 sites

  • Manoria Heart and Critical Care Hospital

    Bhopal, Madhya Pradesh, 462016

  • The Madras Medical Mission

    Chennai, Tamil Nadu, 600037

  • Shri Mahant Indiresh Hospital

    Dehradun, Uttarakhand, 248001

  • Apollo Multispeciality Hospital, Kolkata

    Kolkata, West Bengal, 700054

  • Dayanand Medical College & Hospital

    Ludhiana, Punjab, 141001

  • Arneja Heart & Multispeciality Hospital

    Nagpur, Maharashtra, 440010

  • Gauri Heart Centre

    Srinagar, Jammu and Kashmir, 190015

Other trials in India

Norway5 sites

  • Nordland Hospital Trust

    Bodø, 8005

  • Sykehuset Østfold Kalnes

    Grålum, 1714

  • Colosseumklinikken Medisinske Senter AS

    Oslo, 0369

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, 424

  • Skedsmo Medisinske Senter, Norway

    Skedsmokorset, 2020

Other trials in Norway

Australia4 sites

  • Advara HeartCare

    Auchenflower, Queensland, 4066

  • Barwon Health (The Geelong Hospital)

    Geelong, Victoria, 3220

  • Renal Research Gosford

    Gosford, New South Wales, 2250

  • Advara HeartCare

    Leabrook, South Australia, 5068

Other trials in Australia

United States2 sites

  • Mission Cardiovascular Research Institute

    Fremont, California, 94538

  • Texas Institute of Cardiology PA

    McKinney, Texas, 75071

Other trials in United States

Czechia1 site

  • Nemocnice Na Františku

    Prague, 110 00

Other trials in Czechia

United Kingdom1 site

  • Master Centre for United Kingdom

    Gatwick, West Sussex, RH6 0PA

Other trials in United Kingdom

About this study

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

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.

Being tested
No treatment given
Medical subject headings
Heart Failure, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No treatment givenOther

    No treatment given

Study groups in NCT06122961
Study groupRoleWhat they receive
Atherosclerotic cardiovascular disease (ASCVD) with chronic kidney disease (CKD)electronic case report form (eGFR) below 60 ml/min/1.73m^2
Receives: Other: No treatment given
ASCVD without CKDeGFR greater than or equal to 60 ml/min/1.73m^2
Receives: Other: No treatment given
HF with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF)Not described
Receives: Other: No treatment given
Heart failure (HF) with reduced ejection fraction (HFrEF)Not described
Receives: Other: No treatment given

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. High sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L (yes/ no)

    Count of patient

    Measured: At visit (day 0)

Secondary outcomes (2)

  1. Interleukin 6 (IL-6)

    pg/ml

    Measured: At visit (day 0)

  2. N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

    pg/ml

    Measured: At visit (day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2023
  2. Study start23 Nov 2023
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
18,198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06122961
Sponsor's protocol ID
NN6018-7527
Other IDs
U1111-1286-3420
Acronym
POSEIDON
Status last verified
May 2025
First submitted
3 Nov 2023
Last updated
9 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Risk and Heart Failure, run by Novo Nordisk A/S at 195 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 sites in France, Germany, Italy, South Korea, China and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

High sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L (yes/ no) (time frame: At visit (day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06122961.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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