Dutch University started clinical trial of Myeloid Cell Reprogramming in Aortic Valve Stenosis

Photo by Robina Weermeijer

Radboud University is recruiting patients for the clinical trial of Myeloid Cells in Aortic Valve Stenosis (MIRACLE).

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

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.

The study will take place at the Radboud university medical center, Nijmegen, Netherlands.

Patients who present themselves or are already known at the department of cardiology or cardiothoracic surgery with the diagnosis of moderate or severe aortic valve stenosis as defined by transthoracic echocardiography according to the 2017 ESC/EACTS guidelines for the management of valvular heart disease can be enrolled into this study.

There are a number of conditions that do not allow participation, such as:

  • Auto-inflammatory or auto-immune diseases
  • Use of anti-inflammatory drugs
  • Vaccination less than one month before inclusion
  • Bone marrow transplantation in medical history
  • Active hematological disease.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04717219

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