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RecruitingNCT05851209Updated Jun 30, 2026

Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study

An observational study in Aortic Stenosis, Imaging and Pathogenesis, sponsored by Heinrich-Heine University, Duesseldorf. Recruiting at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Heinrich-Heine University, Duesseldorf · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
938
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • severe aortic stenosis
  • disease progression
  • pathogenesis of degenerative aortic stenosis
  • early detection
  • Cardiovascular magnet resonance
  • Transthoracal echocardiography
  • computertomography
03

In context

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 938 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 180 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a moderate aortic valve stenosis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • The subject has 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
938 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. progress of aortic stenosis

    Prevalence (number of participants) measured by transthoracic echocardiography

    Time frame: 5 years

Secondary outcomes

  1. hospitalization

    Rate of patients (%) being hospitalized due to a progress of aortic stenois

    Time frame: 5 years

  2. death

    Time frame: 5 years

  3. occurence of myocardial infarction

    Time frame: 5 years

  4. occurence of stroke

    Time frame: 5 years

07

Study locations

3 of 3 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Jul 2026, 36 months after the start.

Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 36 months is below that.

Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2023
First posted
May 9, 2023
StartActual
Jul 1, 2023
Primary completionEst.
Jul 2026
CompletionEst.
Jul 2031
Last update
Jun 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05851209
Collaborators
German Research Foundation, University of Bonn, University Cologne, Collaborative Research Center
Responsible party
Sponsor
First posted
May 9, 2023
Start date
Jul 1, 2023
Primary completion
Jul 2026 (estimated)
Completion
Jul 2031 (estimated)
Last update
Jun 30, 2026

Study contacts

Tobias Zeus, MD
Contact
zeus@med.uni-duesseldorf.de
+4921118800
Lisa Dannenberg, MD
Contact
lisa.dannenberg@med.uni-duesseldorf.de
+49211811800
Malte Kelm, Prof.
study chair · Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Georg Nickenig, Prof.
study chair · University of Bonn
Stephan Baldus, Prof.
study chair · University Cologne

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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