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PneumoniaARCADIANCT07357116

Alteration of the Risk of CArdiovascular DIseases After Pneumonia

An observational study of Pneumonia and Cardiovascular Disease (CKD), run by Nantes University Hospital at 1 site in France.

Completed

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

Official record
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Trial summary

Pneumonia can be acquired in the community (CAP) or during hospitalization (HAP). It is a leading cause of communicable diseases and the second cause of disability-adjusted life-years in the world (Roquilly et al., Shankar-Hari et al.). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia, Cardiovascular Disease (CKD)
How many people
2,000,000 participants
Where
1 siteFrance
Study dates
1 Jan 2015to 31 Dec 2024
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: The French National Health Data System (SNDS) is a database that centralizes health-related data covering over 99% of residents (Tuppin et al.). Its primary objective is to support epidemiological research and health care system evaluation. It enables longitudinal analyses of health care pathways by linking data sources through anonymized identifiers. SNDS include information on reimbursed outpatient care and deliveries, hospital discharge summaries and medical procedures, death and related causes and list of pathologies requiring chronic care. These datasets collectively enable large-scale population-based studies on health care utilization, costs, morbidity and mortality. SNDS enable epidemiological studies to be conducted with more than 10 years of hindsight on nearly 68 million people.

Who may be able to join

  • Be at least 18 years of age in the month of the index date.
  • Exposed group: participants who declared pneumonia between January 1, 2015 and November 30, 2024.
  • Unexposed group: participants who did not declare pneumonia between January 1, 2015 and index date and being selected after matching on age, sex, CVD history, chronic kidney disease, diabetes, antihypertensive deliveries, obesity, lipid-lowering treatments, alcohol and tobacco consumption.

Who cannot join

  • Declared pneumonia between January 1, 2012 and December 31, 2014.
  • Pneumonia before the age of 18 between January 1, 2015, and the index date.
  • Organ transplant receiver for any of the following organs before or within one year after the index date: heart, kidney, lung, liver, and pancreas.
  • Identifier that cannot be reliably tracked in the SNDS (such as a fictitious or provisional identifier, or an identifier that, under specific regimen, fails to distinguish same-sex twins in hospital records).
  • Death during index hospitalization.

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU de Nantes

    Nantes, 44093

Other trials in France

About this study

Official title: Alteration of the Risk of CArdiovascular DIseases After Pneumonia: a Nationwide Observational Study Using the French Healthcare Claim Database

Pneumonia can be acquired in the community (CAP) or during hospitalization (HAP). It is a leading cause of communicable diseases and the second cause of disability-adjusted life-years in the world (Roquilly et al., Shankar-Hari et al.). HAP is a common infectious disease, affecting up to 40% of patients on mechanical ventilation. It is a major global concern, with 500,000 cases treated annually in Europe. Despite European guidelines, the incidence remains high (Roquilly et al.), leading to significant medical consequences. Thanks to improved early detection and appropriate medical management, pneumonia-related mortality has steadily declined over the past decades. As a result, the number of patients surviving with potential long-term sequelae has increased, with risks of pulmonary function abnormalities, psychological disorders, and impaired quality of life (Shankar-Hari et al., Sipilä et al., Corrales-Medina et al., Ahmed et al.).

Cardiovascular and respiratory diseases (CVRD) are the most common pre-existing conditions in patients with pneumonia, with up to 40% of patients presenting these comorbidities at the time of pneumonia diagnosis (Roquilly et al., Nojiri et al.). The risk of severe cardiovascular and respiratory events increases after pneumonia recovery, with 14% of patients developing a CVRD event within the first year post-infection (Corrales-Medina et al., Herridge et al.), representing a 40% relative increase in CVRD risk compared to patients with CVRD without infection (Lai et al., Angriman et al.).

The objective of the ARCADIA study is to describe the incidence of cardiovascular diseases (CVD) in individuals surviving pneumonia and to compare it to that of patients with similar predisposing comorbidities for CVD but without a history of pneumonia. The investigators hypothesize that pneumonia is a cause of CVD so that patients with a history of pneumonia have a higher risk of developing CVD.

Read the detailed description

Pneumonia is a leading cause of communicable diseases and the second cause of disability-adjusted life-years in the world (Roquilly et al., Shankar-Hari et al.). Pneumonia can be acquired in the community (community-acquired pneumonia, CAP) or during hospitalization (nosocomial, or Hospital-acquired pneumonia, HAP). CAP is classically induced by virulent bacteria (such as Streptococcus pneumoniae) or viruses (Flu), and new pathogenic viruses such as SARS-CoV2 (COVID-19) can rapidly diffuse in the population.

HAP is a common infectious disease, affecting up to 40% of patients on mechanical ventilation. It is a major global concern, with 500,000 cases treated annually in Europe. Despite European guidelines, the incidence remains high (Roquilly et al.), leading to significant medical consequences. Thanks to improved early detection and appropriate medical management, pneumonia-related mortality has steadily declined over the past decades. As a result, the number of patients surviving with potential long-term sequelae has increased, with risks of pulmonary function abnormalities, psychological disorders, and impaired quality of life (Shankar-Hari et al., Sipilä et al., Corrales-Medina et al., Ahmed et al.).

Cardiovascular and respiratory diseases (CVRD) are the most common pre-existing conditions in patients with pneumonia, with up to 40% of patients presenting these comorbidities at the time of pneumonia diagnosis (Roquilly et al., Nojiri et al.). The risk of severe cardiovascular and respiratory events increases after pneumonia recovery, with 14% of patients developing a CVRD event within the first year post-infection (Corrales-Medina et al., Herridge et al.), representing a 40% relative increase in CVRD risk compared to patients with CVRD without infection (Lai et al., Angriman et al.).

The ARCADIA study is part of the HOMI-LUNG project, funded by the Horizon Europe program. HOMI-LUNG is an international and interdisciplinary initiative aiming to better understand the causal links between respiratory infections (such as pneumonia) and the progression of CVRD. Specifically, the project seeks to quantify the burden of CVRD following pneumonia, assess patient acceptability of long-term health alterations, and define pneumonia endotypes with distinct pathobiological mechanisms associated with CVRD exacerbation.

The objective of the ARCADIA study is to describe the incidence of cardiovascular diseases (CVD) in individuals surviving pneumonia and to compare it to that of patients with similar predisposing comorbidities for CVD but without a history of pneumonia. The investigators hypothesize that pneumonia is a cause of CVD so that patients with a history of pneumonia have a higher risk of developing CVD.

Keywords
pneumonia, cardiovascular sidease, observational study, Routinely Collected Health Data, causality
Medical subject headings
Pneumonia, Cardiovascular Diseases

What participants receive

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

Study groups in NCT07357116
Study groupRoleWhat they receive
Exposed groupExposure is defined as having reported any kind of pneumonia during the inclusion period. Once a participant has developed pneumonia, he or she belongs to the exposed group throughout the follow-up period.
Unexposed groupThe unexposed group is made up of participants who have not developed pneumonia prior to inclusion and who have been matched to a participant in the exposed group on selected confounders.

What is being measured

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

  1. 4-points MACE and 5-points MACE

    Acute events relating to the following pathologies are the main outcomes of the ARCADIA study:

    • Acute Coronary Syndrome (MeSH Unique ID: D054058)
    • Lower limb revascularization or major amputation
    • Ischemic Stroke (D000083242)
    • Heart Failure (D006333) requiring Hospitalization (D006760) The primary outcome is therefore a composite outcome, called "4-points MACE", defined by the occurrence of at least one acute event related to the previously cited pathologies. The incidence of 4-point MACE will be compared between groups using an incidence density ratio (IDR) and its 95% confidence interval.

    This primary analysis will be replicated by adding all-cause mortality (MeSH Unique ID: D003643) to the 4-point MACE described above, defining a 5-points MACE.

    Measured: Up to 10 years

Secondary outcomes (1)
  1. 4-points chronic CVD

    Secondary outcomes gather chronic CVD as follows:

    • Coronary Artery Disease (MeSH Unique ID: D003324)
    • Peripheral Arterial Disease (D058729)
    • Arterial cerebral disease, non-hemorrhagic
    • Heart failure (D006333) We will also consider a composite outcome, called "4-points chronic cardiovascular disease" (4-points chronic CVD), defined by the occurrence or diagnosis related to these pathologies. Its incidence will be compared between groups using an incidence density ratio (IDR) and its 95% confidence interval.

    Measured: Up to 10 years

Timeline

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

  1. First posted21 Jan 2026
  2. Study start1 Jan 2015
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

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
Retrospective
Enrolment
2,000,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357116
Sponsor's protocol ID
RC24_0112_1
Acronym
ARCADIA
Status last verified
Jan 2026
First submitted
3 Dec 2025
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • Tuppin P, Rudant J, Constantinou P, Gastaldi-Menager C, Rachas A, de Roquefeuil L, Maura G, Caillol H, Tajahmady A, Coste J, Gissot C, Weill A, Fagot-Campagna A. Value of a national administrative database to guide public decisions: From the systeme national d'information interregimes de l'Assurance Maladie (SNIIRAM) to the systeme national des donnees de sante (SNDS) in France. Rev Epidemiol Sante Publique. 2017 Oct;65 Suppl 4:S149-S167. doi: 10.1016/j.respe.2017.05.004. Epub 2017 Jul 27.

    PubMed 28756037
  • Angriman F, Rosella LC, Lawler PR, Ko DT, Wunsch H, Scales DC. Sepsis hospitalization and risk of subsequent cardiovascular events in adults: a population-based matched cohort study. Intensive Care Med. 2022 Apr;48(4):448-457. doi: 10.1007/s00134-022-06634-z. Epub 2022 Feb 10.

    PubMed 35142896
  • Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

    PubMed 21470008
  • Ahmed H, Patel K, Greenwood DC, Halpin S, Lewthwaite P, Salawu A, Eyre L, Breen A, O'Connor R, Jones A, Sivan M. Long-term clinical outcomes in survivors of severe acute respiratory syndrome and Middle East respiratory syndrome coronavirus outbreaks after hospitalisation or ICU admission: A systematic review and meta-analysis. J Rehabil Med. 2020 May 31;52(5):jrm00063. doi: 10.2340/16501977-2694.

    PubMed 32449782
  • Corrales-Medina VF, Taljaard M, Yende S, Kronmal R, Dwivedi G, Newman AB, Elkind MS, Lyles MF, Chirinos JA. Intermediate and long-term risk of new-onset heart failure after hospitalization for pneumonia in elderly adults. Am Heart J. 2015 Aug;170(2):306-12. doi: 10.1016/j.ahj.2015.04.028. Epub 2015 May 2.

    PubMed 26299228
  • Lai CC, Lee MG, Lee WC, Chao CC, Hsu TC, Lee SH, Lee CC; National Taiwan University Hospital Health Data Science Research Group. Susceptible period for cardiovascular complications in patients recovering from sepsis. CMAJ. 2018 Sep 10;190(36):E1062-E1069. doi: 10.1503/cmaj.171284.

    PubMed 30201613
  • Nojiri S, Itoh H, Kasai T, Fujibayashi K, Saito T, Hiratsuka Y, Okuzawa A, Naito T, Yokoyama K, Daida H. Comorbidity status in hospitalized elderly in Japan: Analysis from National Database of Health Insurance Claims and Specific Health Checkups. Sci Rep. 2019 Dec 27;9(1):20237. doi: 10.1038/s41598-019-56534-4.

    PubMed 31882961
  • Sipila PN, Heikkila N, Lindbohm JV, Hakulinen C, Vahtera J, Elovainio M, Suominen S, Vaananen A, Koskinen A, Nyberg ST, Pentti J, Strandberg TE, Kivimaki M. Hospital-treated infectious diseases and the risk of dementia: a large, multicohort, observational study with a replication cohort. Lancet Infect Dis. 2021 Nov;21(11):1557-1567. doi: 10.1016/S1473-3099(21)00144-4. Epub 2021 Jun 21.

    PubMed 34166620
  • Shankar-Hari M, Ambler M, Mahalingasivam V, Jones A, Rowan K, Rubenfeld GD. Evidence for a causal link between sepsis and long-term mortality: a systematic review of epidemiologic studies. Crit Care. 2016 Apr 13;20:101. doi: 10.1186/s13054-016-1276-7.

    PubMed 27075205
  • Roquilly A, Chanques G, Lasocki S, Foucrier A, Fermier B, De Courson H, Carrie C, Danguy des Deserts M, Gakuba C, Constantin JM, Lagarde K, Holleville M, Blidi S, Sossou A, Cailliez P, Monard C, Oudotte A, Mathieu C, Bourenne J, Isetta C, Perrigault PF, Lakhal K, Rouhani A, Asehnoune K, Guerci P, Tran Dinh A, Chousterman B, Cupaciu A, Dahyot-Fizelier C, Bellier R, Au Duong J, Mansour A, Morel J, Beauplet G, Vibet MA, Feuillet F, Sebille V, Leone M. Implementation of French Recommendations for the Prevention and the Treatment of Hospital-acquired Pneumonia: A Cluster-randomized Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1601-e1610. doi: 10.1093/cid/ciaa1441.

    PubMed 32970811

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia and Cardiovascular Disease (CKD), run by Nantes University Hospital at 1 site in France.

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 3 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

4-points MACE and 5-points MACE (time frame: Up to 10 years). 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 NCT07357116, which also lists 10 linked publications.

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 24 Jun 2026.

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