Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
A Non-interventional, Prospective, Cross-sectional Study of Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Sars-Cov-2
Hellenic Institute for the Study of Sepsis
650 participants
Nov 8, 2024
OBSERVATIONAL
Conditions
Summary
Pneumonia, which can be acquired in the community (including influenza and COVID-19), is a leading cause of mortality. The risk of severe cardiovascular diseases events (stroke, myocardial infarction, pulmonary embolism) increases after infections, but causal mechanisms are not understood yet. There is an essential need for improved understanding of the relationship between pneumonia and cardiovascular diseases and early identification of patients at risk of cardiovascular events to develop tailored therapies. The overall concept underpinning "Homi-lung" is to investigate the time course of host-microbiome interactions during \& after pneumonia to i) understand the causal relationship between trained immunity, microbiome dysbiosis and cardiovascular and respiratory diseases (CVRD) progressions, ii) define endotypes of pneumonia associated with response to treatment \& CVRD history; iii) develop biomarkers to predict the individual response to the treatment \& CVRD progression, and iv) preclinically validate therapeutical approaches for CVRD during \& after pneumonia.
Eligibility
Inclusion Criteria16
- Group A (healthy controls)
- Adults (18 years or more) of both genders (Female/Male: 50/50 ratio)
- No history of severe pneumonia (sCAP, COVID-19 or HAP)
- Presence of no or one of the following comorbidities: obesity (defined as body mass index over 35 kg/m2), type 2 diabetes mellitus, hypercholesterolemia, essential arterial hypertension, or familial history of CVD.
- Group B (CVRD controls)
- Adults (18 years or more) of both genders (Female/Male ratio: 50/50)
- No history of severe pneumonia (sCAP, COVID-19 or HAP)
- At least two of the following comorbidities: obesity (defined as body mass index over 35 kg/m2), type 2 diabetes mellitus, hypercholesterolemia, essential arterial hypertension, or familial history of CVD
- Group C (COVID-19 survivors)
- Adults (18 years or more) of both genders (Female/Male ratio: 50/50)
- Survivors from severe COVID-19 pneumonia at hospital discharge; all patients had consolidation in chest X-ray or chest computed tomography during acute infection and were treated for pneumonia
- SoC treatment for acute COVID-19 with dexamethasone
- Group D (sCAP survivors)
- Adults (18 years or more) of both genders
- Survivors from sCAP pneumonia; these patients may be either hospitalized in the ward with pO2FiO2 ratio less than 300 or require admission and hospitalization in the Intensive Care Unit.
- SoC treatment for sCAP with antibiotics
Exclusion Criteria19
- Group A (healthy controls)
- Presence of two or more comorbidities
- Any other co-existing disorder generating CVRD symptoms
- Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians
- Pregnancy or lactation
- Group B (CVRD controls)
- Any other co-existing disorder generating CVRD symptoms
- Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians
- Pregnancy or lactation
- Group C (COVID-19 survivors)
- Medical history of severe congestive heart failure (Stage III-IV)
- Medical history of stage III or IV dyspnoea according to the New York Heart Association classification before the acute COVID-19
- Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians
- Pregnancy or lactation
- Group D (sCAP survivors)
- Medical history of severe congestive heart failure (Stage III-IV)
- Medical history of stage III or IV dyspnoea according to the New York Heart Association classification before the sCAP
- Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians
- Pregnancy or lactation
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Interventions
Blood samples: EDTA-plasma (proteome, metabolome and lipidome) and PBMCs (transcriptome, epigenome, immune-phenotype and genetic polymorphism)
* Spirometry for forced expiratory volume in the first, second, total lung capacity and diffusion capacity of carbon monoxide. * ECG, Heart ultrasound and cardiopulmonary exercise stress testing: * NYHA * Rhythm or conduction abnormality (yes/no) * Left ventricular ejection fraction (%) * VO2Max
Locations(17)
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NCT06601998