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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood samples

    Other intervention

    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).

  • Oropharyngeal swabs

    Other intervention

    An oropharyngeal swab will be taken to analyze patients\&#39; upper airway microbiome at inclusion, M6 and M18.

  • ECG

    Other intervention

    Performed at inclusion, M6 and M18

  • Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: Group A : Patients with acute major cardiovascular eventOther 4 interventions
Group B: Group B: Patients with severe chronic cardiovascular diseaseOther 4 interventions
Group C: Group C: Patients with a high risk of CVD, yet no known history of CVRD or HAOther 3 interventions
Group D: Group D: Patients cured of HAPExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Major adverse cardiovascular events (MACE)

Major adverse cardiovascular events (MACE) at 6 months

Time frame
6 months

Secondary outcomes

1

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
2

Rate of thrombo-embolic events

Rates of thrombo-embolic events : pulmonary embolism, deep venous thrombosis

Time frame
Month 6 and Month 18
3

Rate of patients with poor cardiorespiratory fitness

Poor tolerance defined as VO2max lower than the normal values for age

Time frame
6 Month
4

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

Other outcomes

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