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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
300
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).
An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6 and M18.
Performed at inclusion, M6 and M18
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.
Angers University Hospital
Angers, France
NOT_YET_RECRUITINGNantes University Hospital
Nantes, France
RECRUITINGRennes University Hospital
Rennes, France
NOT_YET_RECRUITINGRouen University Hospital
Rouen, France
NOT_YET_RECRUITINGToulouse University Hospital
Toulouse, France
NOT_YET_RECRUITINGMajor adverse cardiovascular events (MACE)
Major adverse cardiovascular events (MACE) at 6 months
Time frame: 6 months
Rate of events
Rate of events : nonfatal stroke, nonfatal myocardial infarction, hospital admission for heart failure, and cardiovascular death
Time frame: Month 6 and Month 18
Rate of thrombo-embolic events
Rates of thrombo-embolic events : pulmonary embolism, deep venous thrombosis
Time frame: Month 6 and Month 18
Rate of patients with poor cardiorespiratory fitness
Poor tolerance defined as VO2max lower than the normal values for age
Time frame: 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
Time frame: 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
Time frame: Month 6 and Month 18
NYHA (New York Heart Association) classification
NYHA (New York Heart Association) classification of dyspnea
Time frame: 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)
Time frame: 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
Time frame: Month 6 and Month 18
Rate of obstructive chronic respiratory distress progression
Rate of obstructive chronic respiratory distress progression
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
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 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 6 and Month 18
Mean QALYs (Quality-Adjusted Life-Years)
Mean QALYs (Quality-Adjusted Life-Years)
Time frame: 18 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
Time frame: Month 6, Month 18 and Month 30
Modelisation of host-microbiome interactions
Modelisation of host-microbiome interactions
Time frame: Month 0, Month 6 and Month 18
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