Investigating cardiovascular disease progression in pneumonia survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between community-acquired pneumonia, including COVID-19 pneumonia, and the subsequent risk of cardiovascular diseases. It will assess the time course of host-microbiome interactions and their impact on cardiovascular and respiratory disease progression. The study will involve collecting blood samples, conducting various tests such as spirometry and ECG, and analyzing patient responses to questionnaires. By identifying biomarkers and endotypes associated with pneumonia, the research seeks to enhance understanding and treatment of cardiovascular risks in these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• 10th Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases
  Athens, Greece Recruiting
• 1st Department of Internal Medicine, General Hospital of Athens G. GENNIMATAS
  Athens, Greece Recruiting
• 1st Department of Internal Medicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.
  Athens, Greece Recruiting
• 1st Department of Internal Medicine, General Hospital of Voula ASKLEPIEIO
  Athens, Greece Recruiting
• 1st Intensive Care Clinic of the Medical School of the University of Athens, Evangelismos General Hospital
  Athens, Greece Recruiting
• 1st University Department of Internal Medicine, General Hospital of Athens LAIKO
  Athens, Greece Recruiting

Study contacts

• Study coordinator: Prof. Evangelos Giamarellos-Bourboulis
• Email: egiamarel@med.uoa.gr
• Phone: 00302105831994

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.