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NCT Number: NCT06602934

Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia

The HOMI-LUNG - HAP study is part of the HOMI-LUNG project, funded by the Horizon Europe program. The "HOMI-LUNG" project is an international, interdisciplinary project that aims to better understand the causal links between respiratory tract infections (i.e. pneumonia) and the progression of cardiovascular disease. More specifically, the project aims to quantify the burden of cardiovascular disease after pneumonia and assess patients; acceptability of long-term health alterations, as well as to define pneumonia endotypes with distinct pathobiological mechanisms associated with exacerbation of cardiovascular disease.

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Key information

Conditions

Hospital Acquired Pneumonia (HAP) Cardiovascular and Respiratory Disease Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angers University Hospital, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Group A (patients with acute cardiac disease)

  • Male or female
  • Hospitalized for acute coronary syndrome for less than 7 days.
  • Informed consent from the patient
  • Person insured under a health insurance scheme

Group B (patients with chronic cardiovascular disease)

  • Male or female,
  • Undergoing coronary artery by-pass surgery
  • Hospitalized in intensive care unit for > 12 hours
  • Informed consent from the patient
  • Person insured under a health insurance scheme

Group C (patients at risk of CVRD without chronic cardiovascular disease)

  • Male or female,
  • Familial high levels of cholesterol or triglycerides
  • With no personal history of CVRD, with a recent negative cardiac exercise test (last test inferior to 12 months)
  • Follow-up for lipid abnormalities at high risk of CVRD events
  • Informed consent from the patient
  • Person insured under a health insurance scheme

Group D (patients with HAP)

  • Male or female
  • With one or more risk factors for CVD among:

Age ≥ 65 years old Smoking, Abnormal lipidic levels, High blood pressure, Obesity, Diabetes mellitus, Chronic kidney disease

  • Cured from mechanically ventilated HAP during the current hospitalization
  • Informed consent from the patient or relatives
  • Person insured under a health insurance scheme

Exclusion criteria

  • Groups A, B, C and D
  • Age <80 years old
  • Immunosuppression pre-existing to the index hospitalisation, defined as lymphopenia; 500 elements/mm3, haematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug.
  • Pregnant women, breastfeeding women.
  • Adults under guardianship or trusteeship.
  • Low probability of survival at day 28.

o Groups A, B, C

  • Community-acquired pneumonia or Hospital-acquired pneumonia within the last year.

Treatment and study plan

Blood Samples

Other

Four blood samples will be taken outside standard care for groups A, B, C and D: at inclusion, M6 and M18 (only at inclusion for group C).

Oropharyngeal swabs

Other

An oropharyngeal swab will be taken to analyze patients&#39; upper airway microbiome at inclusion, M6 and M18.

ECG

Other

Performed at inclusion, M6 and M18

Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration

Other

Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration: These tests will be performed consecutively for 2 hours at inclusion M6 and M18. These tests will be performed to assess respiratory and cardiac function.

Primary outcomes

  1. Major adverse cardiovascular events (MACE)

    Time frame: 6 months

    Major adverse cardiovascular events (MACE) at 6 months

Secondary outcomes

  1. Rate of events

    Time frame: Month 6 and Month 18

    Rate of events : nonfatal stroke, nonfatal myocardial infarction, hospital admission for heart failure, and cardiovascular death

  2. Rate of thrombo-embolic events

    Time frame: Month 6 and Month 18

    Rates of thrombo-embolic events : pulmonary embolism, deep venous thrombosis

  3. Rate of patients with poor cardiorespiratory fitness

    Time frame: 6 Month

    Poor tolerance defined as VO2max lower than the normal values for age

  4. Long-term CVD progression

    Time frame: Month 6 and Month 18

    • Decrease in VO2max measured by cardiopulmonary exercise stress testing
    • - Rates of CVD are defined as
    • % patients with VO2max lower than normal values for age and sex.
    • % patients with new rhythm cardiac alterations, of new repolarisation abnormality

  5. Rates of major respiratory events

    Time frame: Month 6 and Month 18

    Rates of major respiratory events are defined as COPD exacerbation, asthma exacerbation, hospitalization for respiratory failure, and respiratory-related mortality

  6. NYHA (New York Heart Association) classification

    Time frame: Month 6 and Month 18

    NYHA (New York Heart Association) classification of dyspnea

  7. mMRC (Modified Medical Research Council) Dyspnoea Scale

    Time frame: Month 6 and Month 18

    mMRC (Modified Medical Research Council) Dyspnoea Scale (Grade O to 4 : grade O = I only get breathless with strenuous exercise ; grade 4 : I am too breathless to leave the house or I am breathless when dressing/undressing)

  8. Rate of restrictive chronic respiratory distress

    Time frame: Month 6 and Month 18

    Rate of restrictive chronic respiratory distress defined as% of patients withCPT (Total Lung Capacity) lower than normal values

  9. Rate of obstructive chronic respiratory distress progression

    Time frame: Month 6 and Month 18

    Rate of obstructive chronic respiratory distress progression

  10. Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex

    Time frame: Month 6 and Month 18

    Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex

  11. Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex

    Time frame: Month 6 and Month 18

    Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex

  12. Rate of patients with secondary lower respiratory tract infection

    Time frame: Month 6 and Month 18

    Rate of patients with secondary lower respiratory tract infection defined as clinical signs of infection with new infiltrate on Chest-X-Ray

  13. Rate of patients with non-respiratory infection

    Time frame: Month 6 and Month 18

    • Rates of patients with secondary lower respiratory tract infection defined as clinical signs of infection (fever, cough, hyperleukocytosis or leukopenia), with new infiltrate on Chest-X-Ray (performed as standard of care).
    • Rates of patients with non-respiratory infection defined as pyelonephritis, septicemia, skin infection or others.

  14. Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27

    Time frame: Month 6 and Month 18

    Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27

  15. Glasgow Outcome Scale Extended values

    Time frame: Month 6 and Month 18

    Glasgow Outcome Scale Extended values to assess global disability and recovery after traumatic brain injury

  16. Brief Pain Inventory score

    Time frame: Month 6 and Month 18

    BPI score. This self-assessment questionnaire assesses the maind imensions of pain : intensity, functional disability, social and family repercussions and level of psychological distress (scale 0-10 : 0 = no pain , 10 = worst pain)

  17. Rates of patients with chronic pain

    Time frame: Month 6 and Month 18

    Rates of patients with chronic pain (yes/no) as defined as worse pain score value within the last 24 hours superior to 3

  18. Rates of patients with severe symptoms of anxiety

    Time frame: Month 6 and Month 18

    Rates of patients with severe symptoms of anxiety defined as HADS_a and HADS_d >=11

  19. Mean Satisfaction With Life Scale (SWLS) score

    Time frame: Month 6 and Month 18

    Experience of CVRD progression from the patients' perspectives assessed by mean SWLS score

  20. Correlation between SWLS and EQ-5D-5L dimensions and utility scores

    Time frame: Month 6 and Month 18

    Correlation between Satisfaction With Life Scale (SWLS) and 5-level EQ-5D dimensions and utility scores

  21. SF(Short Form)-36 score

    Time frame: Month 6 and Month 18

    Patients' responses to the SF-36 to estimate the change in Health-Related Quality of Life (HRQoL) over time

  22. Mean QALYs (Quality-Adjusted Life-Years)

    Time frame: 18 months

    Mean QALYs (Quality-Adjusted Life-Years)

  23. EPICES (Evaluation of precariousness and health inequalities in health examination centers) score

    Time frame: Month 6, Month 18 and Month 30

    Rate of socio-economical precarity defined as EPICES (Evaluation of precariousness and health inequalities in health examination centers) score values &gt; 30 at M6, 18 and M30

  24. Modelisation of host-microbiome interactions

    Time frame: Month 0, Month 6 and Month 18

    Modelisation of host-microbiome interactions

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine ROQUILLY

CONTACT

[email protected]

+33253482840

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia - the HOMI-LUNG Project - Hospital-Acquired-Pneumonia

Acronym: HOMI-LUNG-HAP

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Jun 4, 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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