Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood samples, Oropharyngeal swabs, ECG, Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration.
- Who it may be relevant to
- Registry conditions: Hospital Acquired Pneumonia (HAP), Cardiovascular and Respiratory Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia - the HOMI-LUNG Project - Hospital-Acquired-Pneumonia
Overview
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.
Interventions
- Other Blood samples
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). - Other Oropharyngeal swabs
An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6 and M18. - Other ECG
Performed at inclusion, M6 and M18 - Other Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration
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.
Primary outcome measures
- Major adverse cardiovascular events (MACE) [Time frame: 6 months]
Secondary outcome measures (12)
- Rate of events [Time frame: Month 6 and Month 18]
- Rate of thrombo-embolic events [Time frame: Month 6 and Month 18]
- Rate of patients with poor cardiorespiratory fitness [Time frame: 6 Month]
- Long-term CVD progression [Time frame: Month 6 and Month 18]
- Rates of major respiratory events [Time frame: Month 6 and Month 18]
- NYHA (New York Heart Association) classification [Time frame: Month 6 and Month 18]
- mMRC (Modified Medical Research Council) Dyspnoea Scale [Time frame: Month 6 and Month 18]
- Rate of restrictive chronic respiratory distress [Time frame: Month 6 and Month 18]
- 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 [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 [Time frame: Month 6 and Month 18]
- Rate of patients with secondary lower respiratory tract infection [Time frame: Month 6 and Month 18]
Eligibility criteria
Inclusion criteria
Group A (patients with acute cardiac disease)
- Male or female
- 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,
- 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,
- 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
- With one or more risk factors for CVD among:
Age ≥ 65 years old 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 5 centers
- Angers University Hospital — Angers
- Nantes University Hospital — Nantes
- Rennes University Hospital — Rennes
- Rouen University Hospital — Rouen
- Toulouse University Hospital — Toulouse
Identifiers
NCT: NCT06602934 · RC24_0112