Status:

UNKNOWN

Myeloid Cells in Aortic Valve Stenosis

Lead Sponsor:

Radboud University Medical Center

Conditions:

Aortic Valve Disease

Aortic Valve Stenosis

Eligibility:

All Genders

18+ years

Brief 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.

Detailed 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 incr...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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 skin carcinoma, 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 which antibiotics have been prescribed, with the exception for the use of nitrofurantoin for a urinary tract infection without fever

Key Trial Info

Start Date :

November 19 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2022

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT04717219

Start Date

November 19 2020

End Date

December 31 2022

Last Update

April 12 2022

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Rijnstate

Arnhem, Netherlands

2

Radboud university medical center

Nijmegen, Netherlands, 6500 GA

3

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands