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Myeloid cell reprogramming in aortic valve stenosis

Myeloid cell reprogramming in aortic valve stenosis - Monocytes in aortic valve stenosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52396
Enrollment
400
Registered
2020-04-28
Start date
2020-11-19
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Aortic valve stenosis cardiac valvular disease

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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. - for the control group: - 150 healthy subjects without aortic valve stenosis - 50 subjects with aortic valve stenosis due to congenital biscuspid valve

Exclusion criteria

Exclusion criteria: For patients and controls: - 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. Extra exclusion for healthy control subjects: - History of atherosclerotic cardiovascular events - Current typical complaints of angina pectoris or intermittent claudication. - Overt heart failure (NYHA class III/IV) - Aortic valve stenosis on screenings echocardiography, that will be performed before inclusion. Mild aortic valve sclerosis is allowed. Extra exclusion for controls with aortic valve stenosis due to a bicuspid valve: - History of atherosclerotic cardiovascular events - Current typical complaints of angina pectoris or intermittent claudication.

Design outcomes

Primary

MeasureTime frame
Frequency of CHIP driver mutations in blood cells.

Secondary

MeasureTime frame
Secondary endpoint is cytokine production capacity of isolated innate immunce cells. Other explorative endpoints include leukocyte composition,cytokine production capacity and ROS production of isolated neutrophils, circulating markers of inflammation, including cytokines and chemokines, circulating metabolome and proteome, deep transcriptional phenotyping of circulating monocytes and neutrophils is a subgroup of patients (from all subjects, these cells will be isolated and stored in liquid nitrogen), detection of epigenetic markers, as a marker for trained immunity, on a selection of samples, histopathological examination of (a selection of) sugically removed valvular tissue. The researcher will call all participants after 2 and 5 year and check medical files to be able to explore whether the immunological parameters are associated with incident cardiovascular events and disease progression.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)