Serum and Cellular Biomarkers for Aortic Valve Stenosis

NCT04312139 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 280

Last updated 2022-10-04

No results posted yet for this study

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

Conditions

  • Calcific Aortic Valve Disease
  • Aortic Valve Stenosis
  • Aortic Valve, Calcification of

Interventions

DIAGNOSTIC_TEST

Echocardiography

Baseline and prospective follow-up echocardiography

DIAGNOSTIC_TEST

Computerized Tomography Aortic Valve Calcium Score

Baseline and prospective follow-up CT calcium score of aortic valve

OTHER

Untargeted LC/MS and LC-MS/MS

Serum samples untargeted proteomics and metabolomics

OTHER

Targeted LC/MS and LC-MS/MS

Serum samples targeted proteomics and metabolomics

DIAGNOSTIC_TEST

multiplex ELISA

Implementation of novel multiplex ELISA assay on serum samples of aortic valve stenosis prospective cohort.

Sponsors & Collaborators

  • Naval Hospital of Athens

    collaborator UNKNOWN
  • Biomedical Research Foundation of the Academy of Athens

    collaborator UNKNOWN
  • University of Oxford

    collaborator OTHER
  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Konstantinos P Toutouzas, Professor · First Department of Cardiology, Athens Medical School, NKUA

Eligibility

Min Age
60 Years
Max Age
87 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2025-03-31
Completion
2025-09-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04312139 on ClinicalTrials.gov