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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: Group A (healthy controls) 1. Adults (18 years or more) of both genders (Female/Male: 50/50 ratio) 2. No history of severe pneumonia (sCAP, COVID-19 or HAP) 3. 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) 1. Adults (18 years or more) of both genders (Female/Male ratio: 50/50) 2. No history of severe pneumonia (sCAP, COVID-19 or HAP) 3. 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) 1. Adults (18 years or more) of both genders (Female/Male ratio: 50/50) 2. 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 3. SoC treatment for acute COVID-19 with dexamethasone Group D (sCAP survivors) 1. Adults (18 years or more) of both genders 2. 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. 3. SoC treatment for sCAP with antibiotics Who Should NOT Join This Trial: Group A (healthy controls) 1. Presence of two or more comorbidities 2. Any other co-existing disorder generating CVRD symptoms 3. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians 4. Pregnancy or lactation Group B (CVRD controls) 1. Any other co-existing disorder generating CVRD symptoms 2. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Group A (healthy controls) 1. Adults (18 years or more) of both genders (Female/Male: 50/50 ratio) 2. No history of severe pneumonia (sCAP, COVID-19 or HAP) 3. 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) 1. Adults (18 years or more) of both genders (Female/Male ratio: 50/50) 2. No history of severe pneumonia (sCAP, COVID-19 or HAP) 3. 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) 1. Adults (18 years or more) of both genders (Female/Male ratio: 50/50) 2. 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 3. SoC treatment for acute COVID-19 with dexamethasone Group D (sCAP survivors) 1. Adults (18 years or more) of both genders 2. 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. 3. SoC treatment for sCAP with antibiotics Exclusion Criteria: Group A (healthy controls) 1. Presence of two or more comorbidities 2. Any other co-existing disorder generating CVRD symptoms 3. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians 4. Pregnancy or lactation Group B (CVRD controls) 1. Any other co-existing disorder generating CVRD symptoms 2. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians 3. Pregnancy or lactation Group C (COVID-19 survivors) 1. Medical history of severe congestive heart failure (Stage III-IV) 2. Medical history of stage III or IV dyspnoea according to the New York Heart Association classification before the acute COVID-19 3. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians 4. Pregnancy or lactation Group D (sCAP survivors) 1. Medical history of severe congestive heart failure (Stage III-IV) 2. Medical history of stage III or IV dyspnoea according to the New York Heart Association classification before the sCAP 3. Limited chance of survival for at least six months due to co-existing comorbidity (-ies) according to the judgement of the attending physicians 4. Pregnancy or lactation

Treatments Being Tested

OTHER

Blood samples and Oropharyngeal swab

Blood samples: EDTA-plasma (proteome, metabolome and lipidome) and PBMCs (transcriptome, epigenome, immune-phenotype and genetic polymorphism)

OTHER

Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptoms

* 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)

2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Alexandroupoli, Greece
10th Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases
Athens, Greece
1st Department of Internal Medicine, General Hospital of Athens G. GENNIMATAS
Athens, Greece
1st Department of Internal Medicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.
Athens, Greece
1st Department of Internal Medicine, General Hospital of Voula ASKLEPIEIO
Athens, Greece
1st Intensive Care Clinic of the Medical School of the University of Athens, Evangelismos General Hospital
Athens, Greece
1st University Department of Internal Medicine, General Hospital of Athens LAIKO
Athens, Greece
1st University Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases
Athens, Greece
2nd Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases
Athens, Greece
3rd University Department of Internal Medicine, Sotiria Athens Hospital of Chest Diseases
Athens, Greece
4th Department of Internal Medicine, ATTIKON University General Hospital
Athens, Greece
Intensive Care Unit, General Hospital of Voula ASKLEPIEIO
Athens, Greece
Out-patients clinic, General Hospital of Voula ASKLEPIEIO
Athens, Greece
1st Department of Internal Medicine, Thriasio General Hospital of Elefsina
Elefsina, Greece
1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
Thessaloniki, Greece
Intensive Care Unit 2, AHEPA University General Hospital of Thessaloniki
Thessaloniki, Greece
Intensive Care Unit, "Ippokrateion" General Hospital of Thessaloniki
Thessaloniki, Greece