Myeloid Cells in Aortic Valve Stenosis

Last updated: April 4, 2022
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Valve Disease

Treatment

N/A

Clinical Study ID

NCT04717219
NL72973.091.20
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Investigators plan to characterize systemic inflammation and circulating immune cells in participants with moderate and severe calcific aortic valve disease and matched healthy controls.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years
  • Mild, moderate or severe degenerative aortic valve stenosis as defined bytransthoracic echocardiography according to the 2017 ESC/EACTS guidelines for themanagement of valvular heart disease.

Exclusion

Exclusion Criteria:

  • Active auto-inflammatory or auto-immune diseases
  • Anti-inflammatory drugs
  • Vaccination less than one month before inclusion
  • Bone marrow transplantation
  • Active malignancy, except for local basal cell carcinoma or local squamous cell skincarcinoma, that can be treated curatively by excision.
  • History of endocarditis of the aortic valve
  • History of radiation therapy aimed at the chest
  • Acute ischemic cardiac event less than three months before inclusion
  • Systemic inflammation less than one month before inclusion with fever and/or for whichantibiotics have been prescribed, with the exception for the use of nitrofurantoin fora urinary tract infection without fever

Study Design

Total Participants: 400
Study Start date:
November 19, 2020
Estimated Completion Date:
December 31, 2022

Study Description

Calcific aortic valve disease (CAVD) is the most common type of valvular heart disease in the Western world. Due to the aging of the population, the impact of this disorder is expected to further increase in the next decades. The underlying pathophysiology remains incompletely defined and there are currently no effective medical treatments capable of altering its course, identifying a major unmet need in this growing population of patients.

Based on the similarities between CAVD and atherosclerosis in pathophysiology and shared risk factors, it is now hypothesized that activation of the innate immune system contributes to the development of CAVD. Therefore, the investigators will perform an observational study to assess the role of activation of the innate immune system in CAVD.

Connect with a study center

  • Rijnstate

    Arnhem,
    Netherlands

    Site Not Available

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen,
    Netherlands

    Site Not Available

  • Radboud university medical center

    Nijmegen, 6500 GA
    Netherlands

    Active - Recruiting

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