Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study

Evaluation of Immunologic and Image Morphologic Parameters to Predict Disease Progression in Patients With Moderate Aortic Valve Stenosis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05851209

Enrollment

938

Registered

2023-05-09

Start date

2023-07-01

Completion date

2031-07-01

Last updated

2026-06-30

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

Conditions

Aortic Stenosis, Aortic Valve Calcification, Disease Progression, Genetics, Imaging, Pathogenesis

Keywords

severe aortic stenosis, disease progression, pathogenesis of degenerative aortic stenosis, early detection, Cardiovascular magnet resonance, Transthoracal echocardiography, computertomography

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
progress of aortic stenosis	5 years	Prevalence (number of participants) measured by transthoracic echocardiography

Secondary

Measure	Time frame	Description
hospitalization	5 years	Rate of patients (%) being hospitalized due to a progress of aortic stenois
death	5 years	—
occurence of myocardial infarction	5 years	—
occurence of stroke	5 years	—

Countries

Germany

Contacts

CONTACTTobias Zeus, MD

zeus@med.uni-duesseldorf.de+4921118800

CONTACTLisa Dannenberg, MD

lisa.dannenberg@med.uni-duesseldorf.de+49211811800

STUDY_CHAIRMalte Kelm, Prof.

Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

STUDY_CHAIRGeorg Nickenig, Prof.

University of Bonn

STUDY_CHAIRStephan Baldus, Prof.

University Cologne

Outcome results