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

Not Applicable

Recruiting

• Conditions: Hospital Acquired Pneumonia (HAP); Cardiovascular and Respiratory Disease
• Interventions: 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

• Registration Number: NCT06602934
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Status Verified: 2025-01
• Study Start: 2025-01-02
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2029-01-02
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA	Blood samples	Comparator
Group A : Patients with acute major cardiovascular event	Blood samples	Comparator
Group D: Patients cured of HAP	ECG	-
Group A : Patients with acute major cardiovascular event	Oropharyngeal swabs	Comparator
Group A : Patients with acute major cardiovascular event	Calcium score (CT scan)	Comparator
Group A : Patients with acute major cardiovascular event	ECG	Comparator
Group A : Patients with acute major cardiovascular event	Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test	Comparator
Group B: Patients with severe chronic cardiovascular disease	Blood samples	Comparator
Group B: Patients with severe chronic cardiovascular disease	Oropharyngeal swabs	Comparator
Group B: Patients with severe chronic cardiovascular disease	Calcium score (CT scan)	Comparator
Group B: Patients with severe chronic cardiovascular disease	ECG	Comparator
Group B: Patients with severe chronic cardiovascular disease	Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test	Comparator
Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA	Oropharyngeal swabs	Comparator
Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA	Calcium score (CT scan)	Comparator
Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA	ECG	Comparator
Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA	Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test	Comparator
Group D: Patients cured of HAP	Blood samples	-
Group D: Patients cured of HAP	Oropharyngeal swabs	-
Group D: Patients cured of HAP	Calcium score (CT scan)	-
Group D: Patients cured of HAP	Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test	-

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events (MACE)	6 months	Major adverse cardiovascular events (MACE) at 6 months
Poor cardiorespiratory fitness	30 months	Poor cardiorespiratory fitness at 30 months. Poor tolerance is a VO2max lower than normal values for age

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Angers University Hospital; 🇫🇷 Angers, France

Rouen University Hospital; 🇫🇷 Rouen, France

Toulouse University Hospital; 🇫🇷 Toulouse, France

Nantes University Hospital; 🇫🇷 Nantes, France

Rennes University Hospital; 🇫🇷 Rennes, France