Myeloid Cells in Aortic Valve Stenosis

Aortic Valve Stenosis Clinical Trial

— MIRACLE  

Official title:

Myeloid Cell Reprogramming in Aortic Valve Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04717219
• Other study ID #: NL72973.091.20
• Status: Recruiting
• Start date: November 19, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Radboud University Medical Center
• Contact: Niels P. Riksen, prof. dr.
• Phone: +31-343618819
• Email: Niels.Riksen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Other:
• Blood drawing
Blood will be drawn after inclusion of the participants.

Locations

Country	Name	City	State
Netherlands	Rijnstate	Arnhem
Netherlands	Canisius Wilhelmina Ziekenhuis	Nijmegen
Netherlands	Radboud university medical center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory phenotype of circulating immune cells.	The inflammatory phenotype of circulating immune cells will be measured by determining the cytokine production capacity after stimulation with relevant stimuli.	2 years