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

Nantes University Hospital (NUH)

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06602934

RC24_0112

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Group A : Patients with acute major cardiovascular event

Other group

Description:

Comparator

Treatment:

Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test

Other: Calcium score (CT scan)

Other: Blood samples

Other: ECG

Other: Oropharyngeal swabs

Group B: Patients with severe chronic cardiovascular disease

Other group

Description:

Comparator

Treatment:

Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test

Other: Calcium score (CT scan)

Other: Blood samples

Other: ECG

Other: Oropharyngeal swabs

Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA

Other group

Description:

Comparator

Treatment:

Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test

Other: Calcium score (CT scan)

Other: Blood samples

Other: ECG

Other: Oropharyngeal swabs

Group D: Patients cured of HAP

Experimental group

Treatment:

Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test

Other: Calcium score (CT scan)

Other: Blood samples

Other: ECG

Other: Oropharyngeal swabs