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Biomarkers and Mechanisms of Disease Progression and Outcome of Aortic Stenosis in Humans

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ClinicalTrials.gov Identifier: NCT05851209
Recruitment Status : Not yet recruiting
First Posted : May 9, 2023
Last Update Posted : May 9, 2023
Sponsor:
Collaborators:
German Research Foundation
University Bonn
University Cologne
Collaborative Research Center
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

Study Description
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Brief Summary:
Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the development of hemodynamically relevant aortic valve stenosis in order to identify high-risk patients and to develop further therapeutic options.

Condition or disease
Aortic Stenosis Imaging Pathogenesis Disease Progression Aortic Valve Calcification Genetics

Detailed Description:

Early recognition and management of aortic stenosis (AS) are substantial to avoid life threatening events during the clinical course. Multi-factorial complex mechanisms including fibrosis, oxidative stress, inflammation, angiogenesis, osteogenic differentiation and the effect of genetic risk variants have been proposed to be involved mechanistically in the pathogenesis of degenerative AS. It is crucial to identify the potentially involved mechanisms of AS progression in order to 1) identify patients at risk for pronounced cardiac damage and adverse outcomes that might benefit from early aortic valve replacement and 2) to discover treatment options that might slow down progression and lower adverse clinical events.

The consortium´s work has revealed that various inflammatory events play a substantial role for the onset and progression of aortic valve calcification and stenosis in cell culture and small animal experiments We hypothesize that patients with and without rapid progress to severe aortic stenosis differ in terms of genetic, immunological and imaging parameters early in the disease course, and that these parameters can be combined to create strong and reliable predictors of disease progression. Hence, we plan to assess multiple morphological, functional, genetic and immunological readouts and investigate their capacity to predict disease progression in AS in a clinical observational cohort of 938 patients with moderate AS.

This project is a working package as part of TRR259, which is a collaborative project between the three universities: Bonn, Cologne and Düsseldorf.

Study Design
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Study Type : Observational
Estimated Enrollment : 938 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Immunologic and Image Morphologic Parameters to Predict Disease Progression in Patients With Moderate Aortic Valve Stenosis
Estimated Study Start Date : July 1, 2023
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2031

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. progress of aortic stenosis [ Time Frame: 5 years ]
    Prevalence (number of participants) measured by transthoracic echocardiography


Secondary Outcome Measures :
  1. hospitalization [ Time Frame: 5 years ]
    Rate of patients (%) being hospitalized due to a progress of aortic stenois

  2. death [ Time Frame: 5 years ]
  3. occurence of myocardial infarction [ Time Frame: 5 years ]
  4. occurence of stroke [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a moderate aortic valve stenosis
Criteria

Inclusion Criteria:

  • The patient has an acquired (tricuspid) moderate aortic valve stenosis, which is the reason for regular outpatient cardiological care.
  • The subject has been informed verbally and in writing about the study and has given written consent to participate in this study.
  • Age > 18 years

Exclusion Criteria:

  • The subject has contraindications for the performance of a magnetic resonance imaging or computed tomography (e.g., severe arrhythmias , contrast agent intolerance, a pacemaker, or severe renal insufficiency or severe renal insufficiency or claustrophobia).
  • Presence of only mild or already high-grade acquired tricuspid Aortic valve stenosis
  • Patient with bicuspid aortic valve
  • Inability to follow the instructions of study personnel
  • Lack of written informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05851209


Contacts
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Contact: Verena Veulemans, MD +4921118800 verena.veulemans@med.uni-duesseldorf.de
Contact: Lisa Dannenberg, MD +49211811800 lisa.dannenberg@med.uni-duesseldorf.de

Locations
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Germany
University-Hospital Bonn
Bonn, Germany, 53127
Contact: Bernando S Franklin, Prof.       ranklin@uni-bonn.de   
Contact: Julian Luetkens, MD       julian.luetkens@ukbonn.de   
Principal Investigator: Bernando S Franklin, Prof.         
Principal Investigator: Julian Luetkens, MD         
Principal Investigator: Jasmin Shameki, MD         
University Hospital Cologne
Cologne, Germany, 50937
Contact: Victor Mauri, MD       victor.mauri@uk-koeln.de   
Principal Investigator: Victor Maudi, MD         
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, Germany, 40225
Contact: Verena Veulemans, MD    +4921118800    verena.veulemans@med.uni-duesseldorf.de   
Contact: Clinical Trial Unit    +49211811800    ctu@med.uni-duesseldorf.de   
Principal Investigator: Verena Veulemans, MD         
Principal Investigator: Malte Kelm, Prof, MD         
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
German Research Foundation
University Bonn
University Cologne
Collaborative Research Center
Investigators
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Study Chair: Malte Kelm, Prof. Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Study Chair: Georg Nickenig, Prof. University Bonn
Study Chair: Stephan Baldus, Prof. University Cologne
More Information
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Additional Information:

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Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT05851209    
Other Study ID Numbers: TRR259 C06
First Posted: May 9, 2023    Key Record Dates
Last Update Posted: May 9, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heinrich-Heine University, Duesseldorf:
severe aortic stenosis
disease progression
pathogenesis of degenerative aortic stenosis
early detection
 Cardiovascular magnet resonance
Transthoracal echocardiography
computertomography
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Disease Progression
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
 Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction