Serum and Cellular Biomarkers for Aortic Valve Stenosis (NCT04312139) | Clinical Trial Compass
UnknownNot Applicable
Serum and Cellular Biomarkers for Aortic Valve Stenosis
Greece280 participantsStarted 2020-03-01
Plain-language summary
AthenaValve aims to develop and initial validate a novel serum diagnostic kit, for the assessment of severity and prognosis of progression of aortic valve stenosis (AS, a devastating disease without early diagnosis and medical treatment). Two independent clinical cohorts of patients will provide serum samples, along with tissue and serum of a validated animal model of the disease for evaluation of the early stages, in order to develop and validate a multiplexed Enzyme-linked Immunosorbent Assay kit (multiplex ELISA). Advanced bioinformatics analysis will facilitate the selection of the most promising molecules from integrated proteomics-transcriptomics-metabolomics data. The novel biomarkers will help clinicians to early diagnose patients at high risk and will pave the way for the experimental implementation of promising pharmaceutical therapies.
Moreover, AthenaValve aims to shed light on the systemic cellular interplay of the same patients, by analyzing the circulating immune cell phenotypes of the subgroups of rapid and slow progression patients
Who can participate
Age range
60 Years – 87 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:
* Retrospective cohort: patients with severe aortic valve stenosis in echocardiography:
• Vmax \> 4 m/sec and mean Gradient \>40 mmHg and/or Aortic Valve Area indexed (AVAi) \< 0.6 cm2/m2 and/or Velocity index \<0.25 whichever worse, with available complete past echocardiographic follow-up (\>2 past studies) indicating disease progression, by the same performing physician.
* Prospective cohort: patients with moderate aortic valve stenosis in echocardiography:
* Vmax 3-4 m/sec and mean Gradient 25-40 mmHg and/or AVAi 0.6-0.9 cm2/m2,
* Where inconsistent: Velocity index = 0.25-0.50.
* Technical details: Optimal doppler measurements obtained by the best feasible echocardiographic window (demonstrating at least 2 windows, where possible including right parasternal with or without pencil probe).
* Prospective Control group: patients at intermediate to high risk for CVD according to atherosclerotic risk factors assessment - Heart Score
Exclusion Criteria:
* Echocardiographic Stroke Volume indexed (SVi) \<35 ml/m2
* Bicuspid aortic valve
* Stenosis of rheumatic etiology
* More than mild aortic valve regurgitation
* More than mild mitral valve regurgitation
* More than mild mitral stenosis
* Severe pulmonary hypertension
* Chronic ischemic heart failure with Ejection Fraction \< 45%
* Right heart failure (based on the echocardiographic assessment of Right Ventricle Dimension, Tricuspid Annular Plane Systolic Excursion, tricuspid annular velocity, and …
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
multiplex ELISA kit Sensitivity
Timeframe: 5 years
2
multiplex ELISA kit Specificity
Timeframe: 5 years
Trial details
NCT IDNCT04312139
SponsorNational and Kapodistrian University of Athens