Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infectio… (NCT06601998) | Clinical Trial Compass
RecruitingNot Applicable
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Greece650 participantsStarted 2024-11-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The first primary outcome is the rates of major cardiovascular disease event at 6 months.
Timeframe: From enrollment to Month 6.
2
The second primary endpoint is poor cardiorespiratory fitness at 36 months.
. 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
Exclusion criteria
. 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
. 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
. Medical history of severe congestive heart failure (Stage III-IV)