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

NCT06602934 | Recruiting

• 1 other identifier: RC24_0112
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Hospital Acquired Pneumonia (HAP); Cardiovascular and Respiratory Disease

Keywords

Hospital-acquired pneumonia; Cardiovascular and respiratory diseases; Respiratory microbiome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (26)

• Health care costs of CVRD progression after HAP

  18 months

• Rate of events

  Month 6 and Month 30

• Rate of thrombo-embolic events

  Month 6 and Month 30

• Rates of CVD

  Month 6 and Month 30

• Rates of major respiratory events

  Month 6 and Month 30

Study Arms (4)

Group A : Patients with acute major cardiovascular event

OTHER

Comparator

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

Group B: Patients with severe chronic cardiovascular disease

OTHER

Comparator

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

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

OTHER

Comparator

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

Group D: Patients cured of HAP

EXPERIMENTAL

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

Interventions

Blood samples OTHER

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).

Group A : Patients with acute major cardiovascular event; Group B: Patients with severe chronic cardiovascular disease; Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA; Group D: Patients cured of HAP

Oropharyngeal swabs OTHER

An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6, M18 and M30.

Group A : Patients with acute major cardiovascular event; Group B: Patients with severe chronic cardiovascular disease; Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA; Group D: Patients cured of HAP

Calcium score (CT scan) OTHER

A calcium score will be taken at 30 months, to assess individual cardiovascular risk.

Group A : Patients with acute major cardiovascular event; Group B: Patients with severe chronic cardiovascular disease; Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA; Group D: Patients cured of HAP

ECG OTHER

Performed at inclusion, M6, M18 and M30

Group A : Patients with acute major cardiovascular event; Group B: Patients with severe chronic cardiovascular disease; Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA; 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 OTHER

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.

Group A : Patients with acute major cardiovascular event; Group B: Patients with severe chronic cardiovascular disease; Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA; Group D: Patients cured of HAP

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• o Groups A, B, C and D
• Age \>80 years old
• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (5)

Angers University Hospital

Angers, France

NOT YET RECRUITING

Nantes University Hospital

Nantes, France

RECRUITING

Rennes University Hospital

Rennes, France

NOT YET RECRUITING

Rouen University Hospital

Rouen, France

NOT YET RECRUITING

Toulouse University Hospital

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Respiration Disorders; Respiratory Tract Diseases

Interventions

Blood Specimen Collection; Exercise Test

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry

Central Study Contacts

Antoine ROQUILLY

CONTACT

+33253482840; Antoine.roquilly@univ-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

FR (5)