Myeloid Cells in Aortic Valve Stenosis

NCT ID: NCT04717219

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-19

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Aortic Valve Disease Aortic Valve Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe CAVD with atherosclerosis

Participants with severe CAVD and significant atherosclerosis

Blood drawing

Intervention Type OTHER

Blood will be drawn after inclusion of the participants.

Severe CAVS without atherosclerosis

Participants with severe CAVD without significant atherosclerosis

Blood drawing

Intervention Type OTHER

Blood will be drawn after inclusion of the participants.

Moderate CAVD with atherosclerosis

Participants with mild or moderate CAVD and significant atherosclerosis

Blood drawing

Intervention Type OTHER

Blood will be drawn after inclusion of the participants.

Moderate CAVD without atherosclerosis

Participants with mild or moderate CAVD without significant atherosclerosis

Blood drawing

Intervention Type OTHER

Blood will be drawn after inclusion of the participants.

Healthy controls

Healthy controls without CAVD and without a history of atherosclerotic cardiovascular events, current typical complaints of angina pectoris or intermittent claudication and overt heart failure (NYHA class III/IV).

Blood drawing

Intervention Type OTHER

Blood will be drawn after inclusion of the participants.

Controls with bicuspid aortic valve stenosis

Controls with bicuspid aortic valve stenosis, without a history of atherosclerotic cardiovascular events, current typical complaints of angina pectoris or intermittent claudication.

Blood drawing

Intervention Type OTHER

Blood will be drawn after inclusion of the participants.

Interventions

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Blood drawing

Blood will be drawn after inclusion of the participants.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Niels Riksen

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niels P. Riksen, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Rijnstate

Arnhem, , Netherlands

Site Status NOT_YET_RECRUITING

Radboud university medical center

Nijmegen, , Netherlands

Site Status RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status NOT_YET_RECRUITING

Countries

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Netherlands

Central Contacts

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Niels P. Riksen, prof. dr.

Role: CONTACT

+31-343618819

Facility Contacts

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R. Pisters, MD, PhD

Role: primary

Niels Riksen, MD, PhD

Role: primary

0031-24-3618819

E.S. Zegers, MD

Role: primary

Other Identifiers

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NL72973.091.20

Identifier Type: -

Identifier Source: org_study_id

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