NCT05851209

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
938

participants targeted

Target at P75+ for all trials

Timeline
62mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

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 Progress36%
Jul 2023Jul 2031

First Submitted

Initial submission to the registry

April 14, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

April 14, 2023

Last Update Submit

May 5, 2023

Conditions

Aortic StenosisImagingPathogenesisDisease ProgressionAortic Valve CalcificationGenetics

Keywords

severe aortic stenosisdisease progressionpathogenesis of degenerative aortic stenosisearly detectionCardiovascular magnet resonanceTransthoracal echocardiographycomputertomography

Outcome Measures

Primary Outcomes (1)

  • progress of aortic stenosis

    Prevalence (number of participants) measured by transthoracic echocardiography

    5 years

Secondary Outcomes (4)

  • hospitalization

    5 years

  • death

    5 years

  • occurence of myocardial infarction

    5 years

  • occurence of stroke

    5 years

Eligibility Criteria

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

Patients with a moderate aortic valve stenosis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University-Hospital Bonn

Bonn, 53127, Germany

Location

University Hospital Cologne

Cologne, 50937, Germany

Location

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Aortic Valve StenosisDisease ProgressionAortic Valve, Calcification of

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    STUDY CHAIR

Central Study Contacts

Verena Veulemans, MD

CONTACT

+4921118800verena.veulemans@med.uni-duesseldorf.de

Lisa Dannenberg, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

May 9, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2031

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

DE(3)