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Myeloid Cells in Aortic Valve Stenosis

Myeloid Cell Reprogramming in Aortic Valve Stenosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04717219
Acronym
MIRACLE
Enrollment
400
Registered
2021-01-22
Start date
2020-11-19
Completion date
2022-12-31
Last updated
2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Aortic Valve Stenosis

Keywords

calcific aortic valve disease, valvular heart disease, inflammation, innate immune cells

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.

Interventions

OTHERBlood drawing

Blood will be drawn after inclusion of the participants.

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Inflammatory phenotype of circulating immune cells.2 yearsThe inflammatory phenotype of circulating immune cells will be measured by determining the cytokine production capacity after stimulation with relevant stimuli.

Countries

Netherlands

Contacts

Primary ContactNiels P. Riksen, prof. dr.
Niels.Riksen@radboudumc.nl+31-343618819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026