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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 range60 Years – 87 Years

SexALL

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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 …

What they're measuring

multiplex ELISA kit Sensitivity

Timeframe: 5 years

multiplex ELISA kit Specificity

Timeframe: 5 years

Trial details

NCT IDNCT04312139

SponsorNational and Kapodistrian University of Athens

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03

Contact for this trial

Nikolaos Anousakis-Vlachochristou, MD

00302132088099 anousakisvn@med.uoa.gr