Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia (HOMI-LUNG-HAP)

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

Study Overview

• Status: Recruiting
• Conditions: Hospital Acquired Pneumonia (HAP); Cardiovascular and Respiratory Disease
• Intervention / Treatment: Other: Blood samples; Other: Oropharyngeal swabs; Other: ECG; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine ROQUILLY; Phone Number: +33253482840; Email: Antoine.roquilly@univ-nantes.fr

Study Locations

• France
  • Angers, France
    • Not yet recruiting
    • Angers University Hospital
    • Contact: Sigismond LASOCKI; Phone Number: +33 2 41 35 36 35; Email: silasocki@chu-angers.fr
    • Principal Investigator: Sigismond Lasocki
  • Nantes, France
    • Recruiting
    • Nantes University Hospital
    • Contact: Antoine ROQUILLY; Phone Number: +33 2 40 58 22 30; Email: Antoine.roquilly@univ-nantes.fr
    • Principal Investigator: Cécile POULAIN
  • Rennes, France
    • Not yet recruiting
    • Rennes University Hospital
    • Contact: Yoann LAUNEY; Phone Number: +33 2 99 28 24 56; Email: yoann.launey@chu-rennes.fr
    • Principal Investigator: Yoann LAUNEY
  • Rouen, France
    • Not yet recruiting
    • Rouen University Hospital
    • Contact: Emmanuel BESNIER; Phone Number: +33 2 32 88 89 90; Email: Emmanuel.Besnier@chu-rouen.fr
    • Principal Investigator: Emmanuel BESNIER
  • Toulouse, France
    • Not yet recruiting
    • Toulouse University Hospital
    • Principal Investigator: Fanny BOUNES
    • Contact: Fanny BOUNES; Phone Number: +33 5 61 32 27 99; Email: bounes.f@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A : Patients with acute major cardiovascular event; Comparator	Other: Blood samples; 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).; Other: Oropharyngeal swabs; An oropharyngeal swab will be taken to analyze patients' upper airway microbiome at inclusion, M6 and M18.; Other: ECG; Performed at inclusion, M6 and M18; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration; 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.
Other: Group B: Patients with severe chronic cardiovascular disease; Comparator	Other: Blood samples; 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).; Other: Oropharyngeal swabs; An oropharyngeal swab will be taken to analyze patients' upper airway microbiome at inclusion, M6 and M18.; Other: ECG; Performed at inclusion, M6 and M18; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration; 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.
Other: Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA; Comparator	Other: Blood samples; 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).; Other: Oropharyngeal swabs; An oropharyngeal swab will be taken to analyze patients' upper airway microbiome at inclusion, M6 and M18.; Other: ECG; Performed at inclusion, M6 and M18
Experimental: Group D: Patients cured of HAP	Other: Blood samples; 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).; Other: Oropharyngeal swabs; An oropharyngeal swab will be taken to analyze patients' upper airway microbiome at inclusion, M6 and M18.; Other: ECG; Performed at inclusion, M6 and M18; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events (MACE)	Major adverse cardiovascular events (MACE) at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EPICES (Evaluation of precariousness and health inequalities in health examination centers) score	Rate of socio-economical precarity defined as EPICES (Evaluation of precariousness and health inequalities in health examination centers) score values > 30 at M6, 18 and M30	Month 6, Month 18 and Month 30
Rate of events	Rate of events : nonfatal stroke, nonfatal myocardial infarction, hospital admission for heart failure, and cardiovascular death	Month 6 and Month 18
Rate of thrombo-embolic events	Rates of thrombo-embolic events : pulmonary embolism, deep venous thrombosis	Month 6 and Month 18
Rate of patients with poor cardiorespiratory fitness	Poor tolerance defined as VO2max lower than the normal values for age	6 Month
Long-term CVD progression	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	Month 6 and Month 18
Rates of major respiratory events	Rates of major respiratory events are defined as COPD exacerbation, asthma exacerbation, hospitalization for respiratory failure, and respiratory-related mortality	Month 6 and Month 18
NYHA (New York Heart Association) classification	NYHA (New York Heart Association) classification of dyspnea	Month 6 and Month 18
mMRC (Modified Medical Research Council) Dyspnoea Scale	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)	Month 6 and Month 18
Rate of restrictive chronic respiratory distress	Rate of restrictive chronic respiratory distress defined as% of patients withCPT (Total Lung Capacity) lower than normal values	Month 6 and Month 18
Rate of obstructive chronic respiratory distress progression	Rate of obstructive chronic respiratory distress progression	Month 6 and Month 18
Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex	Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex	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	Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex	Month 6 and Month 18
Rate of patients with secondary lower respiratory tract infection	Rate of patients with secondary lower respiratory tract infection defined as clinical signs of infection with new infiltrate on Chest-X-Ray	Month 6 and Month 18
Rate of patients with non-respiratory infection	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.	Month 6 and Month 18
Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27	Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27	Month 6 and Month 18
Glasgow Outcome Scale Extended values	Glasgow Outcome Scale Extended values to assess global disability and recovery after traumatic brain injury	Month 6 and Month 18
Brief Pain Inventory score	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)	Month 6 and Month 18
Rates of patients with chronic pain	Rates of patients with chronic pain (yes/no) as defined as worse pain score value within the last 24 hours superior to 3	Month 6 and Month 18
Rates of patients with severe symptoms of anxiety	Rates of patients with severe symptoms of anxiety defined as HADS_a and HADS_d >=11	Month 6 and Month 18
Mean Satisfaction With Life Scale (SWLS) score	Experience of CVRD progression from the patients' perspectives assessed by mean SWLS score	Month 6 and Month 18
Correlation between SWLS and EQ-5D-5L dimensions and utility scores	Correlation between Satisfaction With Life Scale (SWLS) and 5-level EQ-5D dimensions and utility scores	Month 6 and Month 18
SF(Short Form)-36 score	Patients' responses to the SF-36 to estimate the change in Health-Related Quality of Life (HRQoL) over time	Month 6 and Month 18
Mean QALYs (Quality-Adjusted Life-Years)	Mean QALYs (Quality-Adjusted Life-Years)	18 months
Modelisation of host-microbiome interactions	Modelisation of host-microbiome interactions	Month 0, Month 6 and Month 18

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Estimated): July 3, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Hospital-acquired pneumonia; Respiratory microbiome; Cardiovascular and respiratory diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Respiratory Tract Diseases; Respiration Disorders; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Respiratory Function Tests; Ergometry; Exercise Test; Blood Specimen Collection
• Other Study ID Numbers: RC24_0112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No