NCT06122961

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 Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
18,198

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
17 countries

195 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

November 23, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

1.4 years

First QC Date

November 3, 2023

Last Update Submit

May 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Count of patient

    At visit (day 0)

Secondary Outcomes (2)

  • Interleukin 6 (IL-6)

    At visit (day 0)

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

    At visit (day 0)

Study Arms (4)

Atherosclerotic cardiovascular disease (ASCVD) with chronic kidney disease (CKD)

electronic case report form (eGFR) below 60 ml/min/1.73m\^2

Other: No treatment given

ASCVD without CKD

eGFR greater than or equal to 60 ml/min/1.73m\^2

Other: No treatment given

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

Other: No treatment given

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

Other: No treatment given

Interventions

No treatment given

ASCVD without CKDAtherosclerotic cardiovascular disease (ASCVD) with chronic kidney disease (CKD)HF with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF)Heart failure (HF) with reduced ejection fraction (HFrEF)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (195)

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

Texas Institute of Cardiology PA

McKinney, Texas, 75071, United States

Location

Hospital Italiano Regional Sur

Bahía Blanca, Buenos Aires, B8001HXD, Argentina

Location

Clínica Coronel Suarez

Coronel Suárez, Buenos Aires, 7540, Argentina

Location

Hospital Italiano de la Plata

La Plata, Buenos Aires, B 1900AXI, Argentina

Location

Centro Médico CIMEL

Lanús Este, Buenos Aires, B1824KAJ, Argentina

Location

Fundacion Favaloro

CABA, Buenos Aires, Argentina, C1093AAS, Argentina

Location

INECO Neurociencias Oroño

Rosario, Santa Fe Province, 2000, Argentina

Location

DIM Clinica Privada

Buenos Aires, B1704ETD, Argentina

Location

Instituto de Investigaciones Clinicas Quilmes SRL

Buenos Aires, B1878GEG, Argentina

Location

Instituto Médico DAMIC

Córdoba, X5003DCE, Argentina

Location

Hospital Luis Lagomaggiore

Mendoza, M5500, Argentina

Location

Renal Research Gosford

Gosford, New South Wales, 2250, Australia

Location

Advara HeartCare

Auchenflower, Queensland, 4066, Australia

Location

Advara HeartCare

Leabrook, South Australia, 5068, Australia

Location

Barwon Health (The Geelong Hospital)

Geelong, Victoria, 3220, Australia

Location

Sociedade Hospitalar Angelina Caron, Brazil

Campina Grande do Sul, Paraná, 83430-000, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

i9 Pesquisas Clínicas

Campinas, São Paulo, 13092-133, Brazil

Location

Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, 01323-903, Brazil

Location

Nucleo de Pesquisa Clinica do Hospital Vera Cruz

Belo Horizonte/MG, 30220-140, Brazil

Location

Hospital do Coração do Brasil

Brasília, 70390903, Brazil

Location

IPECC - Instituto de Pesquisa Clínica de Campinas

Campinas, 13060-080, Brazil

Location

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

Goiânia, 74605-020, Brazil

Location

ICM - Instituto do Coração de Marília

Marília/SP, 17515-000, Brazil

Location

Instituto D'OR de Pesquisa e Ensino

Rio de Janeiro, 22281-100, Brazil

Location

Hospital Ana Nery

Salvador, 40323-010, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

Sao Jose Rio Preto, 15090-000, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo, 09715-090, Brazil

Location

Universidade Federal de Sao Paulo - UNIFESP

São Paulo, 99999, Brazil

Location

Fraser Clinical Trials Inc.

New West Minster, British Columbia, V3L 3W4, Canada

Location

North Shore Heart Centre

North Vancouver, British Columbia, V7M 2H4, Canada

Location

Cambridge Cardiac Care Centre

Cambridge, Ontario, N1R 6V6, Canada

Location

Kawartha Cardiology Clinical Trials

Peterborough, Ontario, K9J 0B2, Canada

Location

Corcare Cardiovascular Research Inc

Scarborough Village, Ontario, M1B 5N1, Canada

Location

Corcare Cardiovascular Research

Scarborough Village, Ontario, M1B 5N1, Canada

Location

Winchester Dist Memorial Hosp

Winchester, Ontario, K0C 2K0, Canada

Location

[Legal] Viacar Recherches Cliniques, Inc.

Brossard, Quebec, J4Z2K9, Canada

Location

CardioVasc HR Inc

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

Location

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

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

NIS-Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location

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

Guangzhou, Guangdong, 510120, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, 213000, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

China-Japan Union Hospital of Jilin University-Cardiology

Changchun, Jilin, 130033, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

Location

The People's Hospital of Liaoning Province

Shenyang, Liaoning, 110067, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, 150001, China

Location

The Second Hospital of Shandong University

Jinan, 250033, China

Location

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

Xi'an, 710061, China

Location

Nemocnice Na Františku

Prague, 110 00, Czechia

Location

Holbæk Sygehus

Holbæk, Region Sjælland, 4300, Denmark

Location

Bispebjerg og Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Herlev og Gentofte Hospital

Herlev, 2730, Denmark

Location

Regionshospitalet Gødstrup, Hjertesygdomme

Herning, 7400, Denmark

Location

Hillerød Endokrinologisk amb. H0652

Hillerød, 3400, Denmark

Location

Hvidovre Hospital Hjertemedicinsk

Hvidovre, 2650, Denmark

Location

Amager Hospital - Medicinsk Amb

København S, 2300, Denmark

Location

Rigshospitalet

København Ø, 2100, Denmark

Location

Sjællands Universitetshospital_Roskilde

Roskilde, 4000, Denmark

Location

Centre Hospitalier Universitaire Amiens Picardie-Site Sud

Amiens, 80054, France

Location

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre

Bordeaux, 33000, France

Location

Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-1

Bron, 69500, France

Location

Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau

Chambray-lès-Tours, 37170, France

Location

Centre Hospitalier Intercommunal Compiegne - Noyon

Compiègne, 60200, France

Location

Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage

Dijon, 21000, France

Location

Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1

Grenoble, 38043, France

Location

Centre Hospitalier de Versailles-Hopital Andre Mignot

Le Chesnay-Rocquencourt, 78150, France

Location

Les Hopitaux de Chartres-Hopital Louis Pasteur

Le Coudray, 28630, France

Location

Centre Hospitalier Et Universitaire de Limoges-Hopital Dupuytren

Limoges, 87000, France

Location

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69007, France

Location

Clinique Pont de Chaume

Montauban, 82000, France

Location

Centre Hospitalier Universitaire de Montpellier-Hopital Saint-Eloi

Montpellier, 34295, France

Location

Centre Hospitalier Universitaire de Nice-Hopital Pasteur

Nice, 06000, France

Location

Centre Hospitalier Universitaire de Nimes-Hopital Caremeau

Nîmes, 30029, France

Location

Centre Hospitalier Universitaire D'Orleans

Orléans, 45067, France

Location

Ap-Hp-Hopital Hotel Dieu Paris

Paris, 75004, France

Location

Ap-Hp-Hopital Cochin

Paris, 75014, France

Location

Centre Hospitalier de Pau - Hopital Francois Mitterrand

Pau, 64000, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Location

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, 35000, France

Location

Clinique Saint Hilaire

Rouen, 76000, France

Location

Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1

Saint-Herblain, 44800, France

Location

Aura Paris

Saint-Ouen, 93400, France

Location

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

Toulon, 83100, France

Location

Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1

Toulouse, 31059, France

Location

Chru de Nancy - Hopital Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Universitätsklinikum Freiburg Herzzentrum

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

SRH Klinikum Karlsbad - Langensteinbach GmbH - Innere Medizin

Karlsbad, Baden-Wurttemberg, 76307, Germany

Location

Med. Universität Lübeck

Lübeck, EK Uni Lübeck, 23562, Germany

Location

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

Berlin, 12203, Germany

Location

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

Berlin, 13353, Germany

Location

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

Bonn, 53127, Germany

Location

Kardiologisch-Angiologische Praxis Herzzentrum Bremen

Bremen, 28277, Germany

Location

Kath. St. Paulus GmbH - Kardiologie

Dortmund, 44137, Germany

Location

MVZ "Am Felsenkeller" (Dresden)

Dresden, 01277, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, 01307, Germany

Location

DaVita Clinical Research Deutschland GmbH

Düsseldorf, 40210, Germany

Location

Zentrum fuer klinische Studien Suedbrandenburg GmbH

Elsterwerda, 04910, Germany

Location

Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie

Essen, 45147, Germany

Location

Universitätsklinikum Frankfurt aM - Kardiologie

Frankfurt am Main, 60590, Germany

Location

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

Friedrichshafen, 88048, Germany

Location

Universitätsmedizin Göttingen - Dept. Herzzentrum Göttingen

Göttingen, 37075, Germany

Location

UKS - Klinik für Pädiatrische Onkologie und Hämatologie

Homburg/Saar, 66424, Germany

Location

Universitätsklinikum Jena - Kardiologie

Jena, 07747, Germany

Location

Kardiopraxis Schirmer

Kaiserslautern, 67655, Germany

Location

Marienhaus Klinikum Mainz GmbH - Innere Medizin I

Mainz, 55131, Germany

Location

Universitätsmedizin Mainz, Kardiologie I, Studienzentrum

Mainz, 55131, Germany

Location

zero PRAXEN Mannheim-Schwetzingerstadt

Mannheim, 68165, Germany

Location

Klinikum rechts der Isar TU München - Nephrologie

München, 81675, Germany

Location

Universitätsklinikum Tübingen - Innere Medizin III Kardiologie und Angiologie

Tübingen, 72076, Germany

Location

Josephs-Hospital Warendorf - Medizinische Klinik II

Warendorf, 48231, Germany

Location

Al-Zoebi

Wermsdorf, 04779, Germany

Location

Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz

Würzburg, 97078, Germany

Location

Gauri Heart Centre

Srinagar, Jammu and Kashmir, 190015, India

Location

Manoria Heart and Critical Care Hospital

Bhopal, Madhya Pradesh, 462016, India

Location

Arneja Heart & Multispeciality Hospital

Nagpur, Maharashtra, 440010, India

Location

Dayanand Medical College & Hospital

Ludhiana, Punjab, 141001, India

Location

The Madras Medical Mission

Chennai, Tamil Nadu, 600037, India

Location

Shri Mahant Indiresh Hospital

Dehradun, Uttarakhand, 248001, India

Location

Apollo Multispeciality Hospital, Kolkata

Kolkata, West Bengal, 700054, India

Location

Policlinico Mater Domini Università di Catanzaro

Germaneto, Catanzaro, 88100, Italy

Location

Ospedale del Tigullio ASL4 Liguria

Lavagna, Genova, 16033, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

IRCCS Multimedica

Sesto San Giovanni, Milano, 20099, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Complesso Ospedaliero "Nuovo Ospedale di Rivoli"

Rivoli, Torino, 10098, Italy

Location

Ospedale dell'Angelo

Zelarino, Venezia, 30174, Italy

Location

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

University of Brescia

Brescia, 25123, Italy

Location

AO S. Anna e S. Sebastiano

Caserta, 81100, Italy

Location

Presidio Ospedaliero dell'Annunziata

Cosenza, 87100, Italy

Location

IRCCS Azienda Ospedaliero Universitaria San Martino - IST

Genova, 16132, Italy

Location

Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

AORN A. Cardarelli

Napoli, 80100, Italy

Location

Azienda Ospedaliera Universitaria Federico II di Napoli

Napoli, 80131, Italy

Location

A.O.U. Policlinico Giaccone

Palermo, 90127, Italy

Location

Azienda Ospedaliera-Universitaria Parma

Parma, 43126, Italy

Location

AOU Perugia

Perugia, 6129, Italy

Location

Fondazione Toscana G. Monastiero

Pisa, 56126, Italy

Location

ASP Ragusa

Ragusa, 97100, Italy

Location

Arcispedale S Maria Nuova Azienda ULSS-IRCCS

Reggio Emilia, 42123, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, 154, Italy

Location

Fondazione Univ. Policlinico A.Gemelli

Roma, 168, Italy

Location

AOU Sassari

Sassari, 7100, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia

Udine, 33100, Italy

Location

Nordland Hospital Trust

Bodø, 8005, Norway

Location

Sykehuset Østfold Kalnes

Grålum, 1714, Norway

Location

Colosseumklinikken Medisinske Senter AS

Oslo, 0369, Norway

Location

Oslo Universitetssykehus HF, Rikshospitalet

Oslo, 424, Norway

Location

Skedsmo Medisinske Senter, Norway

Skedsmokorset, 2020, Norway

Location

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

Gdynia, Pomeranian Voivodeship, 81-157, Poland

Location

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

Katowice, 40-530, Poland

Location

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

Lodz, 90-549, Poland

Location

Medicome Sp. z o.o.

Oświęcim, 32-600, Poland

Location

NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.

Sopot, 81-852, Poland

Location

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

Szczecin, 71-434, Poland

Location

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

Tychy, 43-100, Poland

Location

4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

Wroclaw, 53-114, Poland

Location

Gachon University Gil Medical Center

Incheon, Timis, 405-220, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Daegu Catholic Univ. Medical Center

Daegu, 42472, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Chungbuk National University Hospital

Daejeon, 361-711, South Korea

Location

Yonsei University Wonju Severance christian hospital

Gangwon-do, 26426, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Hallym University Sacred Heart Hospital

Gyeonggi-do, 14068, South Korea

Location

Kyunghee University Medical Center

Seoul, 02447, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul Saint Mary's Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Danderyd sjukhus

Danderyd, 182 88, Sweden

Location

Medicinkliniken Ryhov

Jönköping, 553 05, Sweden

Location

Centralsjukhuset Karlstad

Karlstad, 652 30, Sweden

Location

Skane University Hospital

Lund, 22185, Sweden

Location

Universitetssjukhuset Örebro

Örebro, 701 85, Sweden

Location

Sodersjukhuset AB

Stockholm, 118 67, Sweden

Location

Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl

Stockholm, 171 64, Sweden

Location

Akademiska sjukhuset Uppsala

Uppsala, 75185, Sweden

Location

Master Centre for United Kingdom

Gatwick, West Sussex, RH6 0PA, United Kingdom

Location

MeSH Terms

Conditions

Heart FailureRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Transparency (dept. 2834)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 8, 2023

Study Start

November 23, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

More information

Locations