Clinical trial • Phase IV • Cardiology
Clinical trial in Aortic stenosis
Phase IV trial for Aortic stenosis. 300 participants.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Aortic stenosis
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 03-12-2024
- First CTIS Authorization Date
- 07-07-2025
Trial design
Phase IV trial in Austria, Germany.
- Target Sample Size
- 300
- Trial Duration For Participant
- 365
Eligibility
Recruits 300 Vulnerable populations are flagged (isVulnerablePopulationSelected=true). Consent must be signed by the subject prior to any study intervention ("Informed Consent must be signed by the subject prior to any study intervention."). Subjects unable to give consent or follow procedures (e.g. due to language problems, psychological disorders, dementia) are excluded. No assent or proxy-consent process is described in the available documents..
- Pregnancy Exclusion
- Pregnancy or breast feeding women.
- Vulnerable Population
- Vulnerable populations are flagged (isVulnerablePopulationSelected=true). Consent must be signed by the subject prior to any study intervention ("Informed Consent must be signed by the subject prior to any study intervention."). Subjects unable to give consent or follow procedures (e.g. due to language problems, psychological disorders, dementia) are excluded. No assent or proxy-consent process is described in the available documents.
Inclusion criteria
- {"criterion_text":"- Informed Consent must be signed by the subject prior to any study intervention."}
- {"criterion_text":"- Adult patients (› 18 years) with severe symptomatic aortic stenosis eligible and scheduled for elective TAVR and are able to give consent."}
- {"criterion_text":"- Indication for B-blocker therapy with a prior treatment duration of at least 1 month before inclusion."}
Exclusion criteria
- {"criterion_text":"- Emergency or urgent indication for TAVR."}
- {"criterion_text":"- Being in a dependent relationship with the trial site."}
- {"criterion_text":"- Participation in another study with investigational drug within the 30 days preceding and during the present study."}
- {"criterion_text":"- Previous enrolment into the current study."}
- {"criterion_text":"- Pregnancy or breast feeding women."}
- {"criterion_text":"- Hemodynamically unstable patients receiving inotropic medication."}
- {"criterion_text":"- Prior permanent pacemaker implantation."}
- {"criterion_text":"- Existing indication for pacemaker implantation."}
- {"criterion_text":"- Hemodynamic relevant left ventricular outflow tract obstruction."}
- {"criterion_text":"- Prior intolerance of B-blocker medication."}
- {"criterion_text":"- Life expectancy ‹ 1 year."}
- {"criterion_text":"- Known or suspected non-compliance, drug, or alcohol abuse."}
- {"criterion_text":"- Inability to give consent, or follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Composite endpoint of all-cause mortality, rehospitalization due to heart failure, stroke, severe arrhythmia (new onset atrial fibrillation/flutter, ventricular tachycardia/ventricular fibrillation, new high-grade AV-Block) at 30 days","definition_or_measurement_approach":"Composite measured as occurrence of any of the listed events at 30 days post-procedure (all-cause mortality, rehospitalization for heart failure, stroke, severe arrhythmia as specified)."}
Secondary endpoints
- {"endpoint_text":"- Pacemaker Rate at 30 days and at 1 year","definition_or_measurement_approach":"Occurrence/rate of pacemaker implantation assessed at 30 days and at 1 year."}
- {"endpoint_text":"- Stroke Rate at 30 days and at 1 year","definition_or_measurement_approach":"Occurrence/rate of stroke assessed at 30 days and at 1 year."}
- {"endpoint_text":"- All-cause mortality at 30 days and 1 year","definition_or_measurement_approach":"All-cause mortality assessed at 30 days and at 1 year."}
- {"endpoint_text":"- Cardiovascular mortality at 30 days and 1 year","definition_or_measurement_approach":"Cardiovascular-cause mortality assessed at 30 days and at 1 year."}
- {"endpoint_text":"- Re-hospitalization due to heart failure at 30 days and at 1 year","definition_or_measurement_approach":"Occurrence/rate of rehospitalization for heart failure assessed at 30 days and at 1 year."}
- {"endpoint_text":"- Severe arrhythmia requiring treatment (e.g.: new onset atrial fibrillation/flutter, ventricular tachycardia /ventricular fibrillation, new AV Block (I, II or III), new left bundle branch block, new right bundle branch block, intraventricular conduction delay (QRS ≥120ms), new severe bradycardia (HR <60 bpm) requiring treatment or tachycardia (‹40bpm or ›120bpm), sick sinus syndrome, new tachycardia (HR>120 bpm) at 30 days and at 1 year","definition_or_measurement_approach":"Occurrence of severe arrhythmias requiring treatment, as listed, assessed at 30 days and at 1 year."}
Recruitment
- Planned Sample Size
- 300
- Recruitment Window Months
- 35
- Consent Approach
- Informed consent must be signed by the subject prior to any study intervention. Subject information and informed consent forms for adults are provided (site-specific ICFs listed). No assent process or proxy consent procedures are described in the available records.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 400
Austria
- Earliest CTIS Part Ii Submission Date
- 26-06-2025
- Latest Decision Or Authorization Date
- 07-07-2025
- Processing Time Days
- 11
- Number Of Sites
- 2
- Number Of Participants
- 100
Sites
- Site Name
- Medical University of Graz, Department of Internal Medicine, University Heart Centre Graz
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Gabor G Toth
- Principal Investigator Email
- gabor.g.toth@medunigraz.at
- Contact Person Name
- Gabor G Toth
- Contact Person Email
- gabor.g.toth@medunigraz.at
- Site Name
- University Hospital Salzburg
- Department Name
- University Clinic for Internal Medicine II, Cardiology
- Principal Investigator Name
- Matthias Hammerer
- Principal Investigator Email
- M.Hammerer@salk.at
- Contact Person Name
- Matthias Hammerer
- Contact Person Email
- M.Hammerer@salk.at
Germany
- Earliest CTIS Part Ii Submission Date
- 13-06-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 315
- Number Of Sites
- 5
- Number Of Participants
- 300
Sites
- Site Name
- Kerckhoff-Klinik GmbH
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Samuel T. Sossalla
- Principal Investigator Email
- s.sossalla@kerckhoff-klinik.de
- Contact Person Name
- Samuel T. Sossalla
- Contact Person Email
- s.sossalla@kerckhoff-klinik.de
- Site Name
- Universitaetsklinikum Giessen und Marburg GmbH
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Samuel T. Sossalla
- Principal Investigator Email
- Samuel.Sossalla@innere.med.uni-giessen.de
- Contact Person Name
- Samuel T. Sossalla
- Contact Person Email
- Samuel.Sossalla@innere.med.uni-giessen.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Campus Kiel, Department of Internal Medicine III, Cardiology, Angiology and Intensive Care
- Principal Investigator Name
- Derk Frank
- Principal Investigator Email
- Derk.Frank@uksh.de
- Contact Person Name
- Derk Frank
- Contact Person Email
- Derk.Frank@uksh.de
- Site Name
- Herz- und Diabeteszentrum NRW Universitätsklinik, Ruhr-Universität Bochum
- Department Name
- Clinic for General and Interventional Cardiology/Angiology
- Principal Investigator Name
- Tanja Rudolph
- Principal Investigator Email
- trudolph@hdz-nrw.de
- Contact Person Name
- Tanja Rudolph
- Contact Person Email
- trudolph@hdz-nrw.de
- Site Name
- University Medical Center Freiburg, University Heart Center
- Department Name
- Deaprtment of Cardiology and Angiology
- Principal Investigator Name
- Mirjam G. Wild
- Principal Investigator Email
- mirjam.wild@uniklinik-freiburg.de
- Contact Person Name
- Mirjam G. Wild
- Contact Person Email
- mirjam.wild@uniklinik-freiburg.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsspital Basel
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Switzerland
Investigational products
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 200 mg
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 50 mg
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 400 mg
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 50 mg
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 640 mg
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