Clinical trial NCT06602934: Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia
Official title: Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia - the HOMI-LUNG Project - Hospital-Acquired-Pneumonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hospital Acquired Pneumonia (HAP)
Cardiovascular and Respiratory Disease
Keywords: Hospital-acquired pneumonia
Cardiovascular and respiratory diseases
Respiratory microbiome
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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\&#39; acceptability of long-term health alterations, as well as to define pneumonia endotypes with distinct pathobiological mechanisms associated with exacerbation of cardiovascular disease.


Eligibility criteria: 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 \&gt; 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 \&gt;80 years old
* Immunosuppression pre-existing to the index hospitalisation, defined as lymphopenia \&lt; 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.

Primary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 6 months
measure: Poor cardiorespiratory fitness
timeFrame: 30 months
Secondary outcomes:
measure: Health care costs of CVRD progression after HAP
timeFrame: 18 months
measure: Rate of events
timeFrame: Month 6 and Month 30
measure: Rate of thrombo-embolic events
timeFrame: Month 6 and Month 30
measure: Rates of CVD
timeFrame: Month 6 and Month 30
measure: Rates of major respiratory events
timeFrame: Month 6 and Month 30
measure: NYHA (New York Heart Association) classification
timeFrame: Month 6, Month 18 and Month 30
measure: mMRC (Modified Medical Research Council) Dyspnoea Scale
timeFrame: Month 6, Month 18 and Month 30
measure: Rate of restrictive chronic respiratory distress
timeFrame: Month 6 and Month 30
measure: Rate of obstructive chronic respiratory distress progression
timeFrame: Month 6 and Month 30
measure: Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex
timeFrame: Month 6 and Month 30
measure: Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex
timeFrame: Month 6 and Month 30
measure: Rate of patients with secondary lower respiratory tract infection
timeFrame: Month 6 and Month 30
measure: Rate of patients with non-respiratory infection
timeFrame: Month 6 and Month 30
measure: Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27
timeFrame: Month 6 and Month 30
measure: Glasgow Outcome Scale Extended values
timeFrame: Month 6 and Month 30
measure: Brief Pain Inventory score
timeFrame: Month 6, Month 18 and Month 30
measure: Rates of patients with chronic pain
timeFrame: Month 6, Month 18 and Month 30
measure: Rates of patients with severe symptoms of anxiety
timeFrame: Month 6, Month 18 and Month 30
measure: Mean Satisfaction With Life Scale (SWLS) score
timeFrame: Month 6, Month 18 and Month 30
measure: Correlation between SWLS and EQ-5D-5L dimensions and utility scores
timeFrame: Month 6, Month 18 and Month 30
measure: SF(Short Form)-36 score
timeFrame: Month 6, Month 18 and Month 30
measure: Fatigue Severity Scale
timeFrame: Month 6, Month 18 and Month 30
measure: Mean QALYs (Quality-Adjusted Life-Years)
timeFrame: 30 months
measure: EPICES (Evaluation of precariousness and health inequalities in health examination centers) score
timeFrame: Month 6, Month 18 and Month 30
measure: Modelisation of host-microbiome interactions
timeFrame: Month 0, Month 6, Month 18 and Month 30
measure: CVD progression
timeFrame: Month 6 and Month 30
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
References: