NCT04717219

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

January 11, 2021

Last Update Submit

April 4, 2022

Conditions

Aortic Valve DiseaseAortic Valve Stenosis

Keywords

calcific aortic valve diseasevalvular heart diseaseinflammationinnate immune cells

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

Severe CAVD with atherosclerosis

Participants with severe CAVD and significant atherosclerosis

Other: Blood drawing

Severe CAVS without atherosclerosis

Participants with severe CAVD without significant atherosclerosis

Other: Blood drawing

Moderate CAVD with atherosclerosis

Participants with mild or moderate CAVD and significant atherosclerosis

Other: Blood drawing

Moderate CAVD without atherosclerosis

Participants with mild or moderate CAVD without significant atherosclerosis

Other: Blood drawing

Healthy controls

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).

Other: Blood drawing

Controls with bicuspid aortic valve stenosis

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

Other: Blood drawing

Interventions

Blood drawingOTHER

Blood will be drawn after inclusion of the participants.

Controls with bicuspid aortic valve stenosisHealthy controlsModerate CAVD with atherosclerosisModerate CAVD without atherosclerosisSevere CAVD with atherosclerosisSevere CAVS without atherosclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • Active auto-inflammatory or auto-immune diseases
  • Anti-inflammatory drugs
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rijnstate

Arnhem, Netherlands

NOT YET RECRUITING

Radboud university medical center

Nijmegen, 6500 GA, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve DiseaseAortic Valve StenosisHeart Valve DiseasesInflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Niels P. Riksen, prof. dr.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels P. Riksen, prof. dr.

CONTACT

+31-343618819Niels.Riksen@radboudumc.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 22, 2021

Study Start

November 19, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

NL(3)