Clinical trial NCT04717219: Myeloid Cells in Aortic Valve Stenosis
Official title: Myeloid Cell Reprogramming in Aortic Valve Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Disease
Aortic Valve Stenosis
Keywords: calcific aortic valve disease
valvular heart disease
inflammation
innate immune cells
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present themselves or are already known at the department of cardiology or cardiothoracic surgery with the diagnosis of moderate or severe aortic valve stenosis as defined by transthoracic echocardiography according to the 2017 ESC/EACTS guidelines for the management of valvular heart disease.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 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 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

Primary outcomes:
measure: Inflammatory phenotype of circulating immune cells.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
Study officials:
affiliation: Radboud University Medical Center
name: Niels P. Riksen, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: