Myeloid Cells in Aortic Valve Stenosis (MIRACLE)

Radboud University Medical Center

Status: Unknown

Conditions: Aortic Valve Stenosis; Aortic Valve Disease

Treatments: Other: Blood drawing

Study type: Observational

Funder types: Other

Identifiers

NCT04717219

NL72973.091.20

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 6 patient groups

Severe CAVD with atherosclerosis

Description:

Participants with severe CAVD and significant atherosclerosis

Treatment:

Other: Blood drawing

Severe CAVS without atherosclerosis

Description:

Participants with severe CAVD without significant atherosclerosis

Treatment:

Other: Blood drawing

Moderate CAVD with atherosclerosis

Description:

Participants with mild or moderate CAVD and significant atherosclerosis

Treatment:

Other: Blood drawing

Moderate CAVD without atherosclerosis

Description:

Participants with mild or moderate CAVD without significant atherosclerosis

Treatment:

Other: Blood drawing

Healthy controls

Description:

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).

Treatment:

Other: Blood drawing

Controls with bicuspid aortic valve stenosis

Description:

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

Treatment:

Other: Blood drawing