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: Calcium score (CT scan); Other: ECG; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test

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

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
• Age ≥ 40years old
• 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,
• Age ≥ 40 years old
• 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,
• Age ≥ 40 years old
• 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
• Age ≥ 40years old
• With one or more risk factors for CVD among:

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:

• o 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, M18 and M30 (only at inclusion for group C).; Other: Oropharyngeal swabs; An oropharyngeal swab will be taken to analyze patients' upper airway microbiome at inclusion, M6, M18 and M30.; Other: Calcium score (CT scan); A calcium score will be taken at 30 months, to assess individual cardiovascular risk.; Other: ECG; Performed at inclusion, M6, M18 and M30; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test; Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test: These tests will be performed consecutively for 2 hours at inclusion (6-minute walk test only), at M6 and at M30. 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, M18 and M30 (only at inclusion for group C).; Other: Oropharyngeal swabs; An oropharyngeal swab will be taken to analyze patients' upper airway microbiome at inclusion, M6, M18 and M30.; Other: Calcium score (CT scan); A calcium score will be taken at 30 months, to assess individual cardiovascular risk.; Other: ECG; Performed at inclusion, M6, M18 and M30; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test; Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test: These tests will be performed consecutively for 2 hours at inclusion (6-minute walk test only), at M6 and at M30. 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, M18 and M30 (only at inclusion for group C).; Other: Oropharyngeal swabs; An oropharyngeal swab will be taken to analyze patients' upper airway microbiome at inclusion, M6, M18 and M30.; Other: Calcium score (CT scan); A calcium score will be taken at 30 months, to assess individual cardiovascular risk.; Other: ECG; Performed at inclusion, M6, M18 and M30; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test; Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test: These tests will be performed consecutively for 2 hours at inclusion (6-minute walk test only), at M6 and at M30. These tests will be performed to assess respiratory and cardiac function.
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, M18 and M30 (only at inclusion for group C).; Other: Oropharyngeal swabs; An oropharyngeal swab will be taken to analyze patients' upper airway microbiome at inclusion, M6, M18 and M30.; Other: Calcium score (CT scan); A calcium score will be taken at 30 months, to assess individual cardiovascular risk.; Other: ECG; Performed at inclusion, M6, M18 and M30; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test; Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test: These tests will be performed consecutively for 2 hours at inclusion (6-minute walk test only), at M6 and at M30. 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
Poor cardiorespiratory fitness	Poor cardiorespiratory fitness at 30 months. Poor tolerance is a VO2max lower than normal values for age	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care costs of CVRD progression after HAP	Health care costs of CVRD progression after HAP over 18 months	18 months
Rate of events	Rate of events : nonfatal stroke, nonfatal myocardial infarction, hospital admission for heart failure, and cardiovascular death	Month 6 and Month 30
Rate of thrombo-embolic events	Rates of thrombo-embolic events : pulmonary embolism, deep venous thrombosis	Month 6 and Month 30
Rates of CVD	Rates of CVD	Month 6 and Month 30
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 at 6 and 30 months	Month 6 and Month 30
NYHA (New York Heart Association) classification	NYHA (New York Heart Association) classification of dyspnea	Month 6, Month 18 and Month 30
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, Month 18 and Month 30
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 30
Rate of obstructive chronic respiratory distress progression	Rate of obstructive chronic respiratory distress progression	Month 6 and Month 30
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 30
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 30
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 30
Rate of patients with non-respiratory infection	Rate of patients with non-respiratory infection	Month 6 and Month 30
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 at M6 and at M30	Month 6 and Month 30
Glasgow Outcome Scale Extended values	Glasgow Outcome Scale Extended values to assess global disability and recovery after traumatic brain injury	Month 6 and Month 30
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, Month 18 and Month 30
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, Month 18 and Month 30
Rates of patients with severe symptoms of anxiety	Rates of patients with severe symptoms of anxiety defined as HADS_A greater than or equal to 11	Month 6, Month 18 and Month 30
Mean Satisfaction With Life Scale (SWLS) score	Experience of CVRD progression from the patients' perspectives assessed by mean SWLS score	Month 6, Month 18 and Month 30
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, Month 18 and Month 30
SF(Short Form)-36 score	Patients' responses to the SF-36 at months 6, 18 and 30 in order to estimate the change in Health-Related Quality of Life (HRQoL) over time	Month 6, Month 18 and Month 30
Fatigue Severity Scale	Patients' responses to the Fatigue Severity Scale at month 6, 18 and 30 in order to estimate change in perceived fatigue over time	Month 6, Month 18 and Month 30
Mean QALYs (Quality-Adjusted Life-Years)	Mean QALYs (Quality-Adjusted Life-Years) at 30 months	30 months
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
Modelisation of host-microbiome interactions	Modelisation of host-microbiome interactions	Month 0, Month 6, Month 18 and Month 30
CVD progression	CVD progression at Month 6 and Month 30	Month 6 and Month 30

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): May 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

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; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Disease Progression; Pneumonia; Respiratory Tract Diseases; Respiration Disorders; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Neurotransmitter Agents; Gasotransmitters; Calcium; Carbon Monoxide
• 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