Aortic StenosisNCT05851209
Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study
An observational study of Aortic Stenosis and Imaging, run by Heinrich-Heine University, Duesseldorf at 3 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Imaging, Pathogenesis
- How many people
- 938 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Jul 2023to Jul 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a moderate aortic valve stenosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
University-Hospital Bonn
Bonn, 53127
Bernando S Franklin, Prof., ranklin@uni-bonn.de
Julian Luetkens, MD, julian.luetkens@ukbonn.de
- Recruiting
University Hospital Cologne
Cologne, 50937
Victor Mauri, MD, victor.mauri@uk-koeln.de
Victor Maudi, MD
- Recruiting
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
Tobias Zeus, MD, +4921118800, zeus@med.uni-duesseldorf.de
Clinical Trial Unit, +49211811800, ctu@med.uni-duesseldorf.de
About this study
Official title: Evaluation of Immunologic and Image Morphologic Parameters to Predict Disease Progression in Patients With Moderate Aortic Valve Stenosis
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.
- Conditions
- 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
- Medical subject headings
- Aortic Valve Stenosis, Disease Progression, Aortic Valve, Calcification of
What is being measured
The primary outcome is the main question the study is designed to answer.
progress of aortic stenosis
Prevalence (number of participants) measured by transthoracic echocardiography
Measured: 5 years
Secondary outcomes (4)
hospitalization
Rate of patients (%) being hospitalized due to a progress of aortic stenois
Measured: 5 years
death
Measured: 5 years
occurence of myocardial infarction
Measured: 5 years
occurence of stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Jul 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 938 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, University of Bonn, University of Cologne, Collaborative Research Center
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, Prof., Study chair, Clinic for Cardiology, Pneumology and Angiology at University Hospital DüsseldorfGeorg Nickenig, Prof., Study chair, University of BonnStephan Baldus, Prof., Study chair, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851209
- Sponsor's protocol ID
- TRR259 C06
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunologic and Image Morphologic Parameters to Predict Disease Progression in Patients With Moderate Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT05851209
- Acronym / sponsor ID
- TRR259 C06
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 938 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- German Research Foundation, University of Bonn, University of Cologne, Collaborative Research Center
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a moderate aortic valve stenosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progress of aortic stenosis
Time frame: 5 years
Prevalence (number of participants) measured by transthoracic echocardiography
4 secondary outcomes
hospitalization
Time frame: 5 years
death
Time frame: 5 years
occurence of myocardial infarction
Time frame: 5 years
occurence of stroke
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Website of TRR259Link provided by the sponsor.
Related trials for Aortic Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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 of Cologne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Imaging, run by Heinrich-Heine University, Duesseldorf at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Zeus, MD (+4921118800, zeus@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress of aortic stenosis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.