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Completed

NCT Number: NCT07357116

Alteration of the Risk of CArdiovascular DIseases After Pneumonia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 4-points MACE and 5-points MACE

    Time frame: Up to 10 years

    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.

Secondary outcomes

  1. 4-points chronic CVD

    Time frame: Up to 10 years

    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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: ARCADIA

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Jan 21, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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