Investigating cardiovascular disease progression in pneumonia survivors
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 · NCT06601998
This study is trying to see how surviving pneumonia, including COVID-19, affects the risk of heart problems later on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 650 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hellenic Institute for the Study of Sepsis (other) |
| Drugs / interventions | canakinumab |
| Locations | 17 sites (Alexandroupoli and 16 other locations) |
| Trial ID | NCT06601998 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are either healthy controls, have cardiovascular risk factors, or are survivors of severe COVID-19 pneumonia.
Not a fit: Patients with a history of severe pneumonia or those without any comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of cardiovascular risks in pneumonia survivors.
How similar studies have performed: While the relationship between pneumonia and cardiovascular disease is recognized, this specific approach to studying it is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Alexandroupoli and 16 other locations
- 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis — Alexandroupoli, Greece (NOT_YET_RECRUITING)
- 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)
- 1st University Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases — Athens, Greece (RECRUITING)
- 2nd Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases — Athens, Greece (RECRUITING)
- 3rd University Department of Internal Medicine, Sotiria Athens Hospital of Chest Diseases — Athens, Greece (RECRUITING)
- 4th Department of Internal Medicine, ATTIKON University General Hospital — Athens, Greece (RECRUITING)
- Intensive Care Unit, General Hospital of Voula ASKLEPIEIO — Athens, Greece (RECRUITING)
- Out-patients clinic, General Hospital of Voula ASKLEPIEIO — Athens, Greece (RECRUITING)
- 1st Department of Internal Medicine, Thriasio General Hospital of Elefsina — Elefsina, Greece (NOT_YET_RECRUITING)
- 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki — Thessaloniki, Greece (NOT_YET_RECRUITING)
- Intensive Care Unit 2, AHEPA University General Hospital of Thessaloniki — Thessaloniki, Greece (NOT_YET_RECRUITING)
- Intensive Care Unit, "Ippokrateion" General Hospital of Thessaloniki — Thessaloniki, Greece (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Prof. Evangelos Giamarellos-Bourboulis
- Email: egiamarel@med.uoa.gr
- Phone: 00302105831994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pneumonia, Community-Acquired, COVID-19 Pneumonia, Cardiovascular Diseases, Covid-19, SARS-CoV-2, Lung infection, Cardiovascular disease, Respiratory disease