Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
700
Countries
2
Sites
7
Aortic stenosis
The aim of the study is to investigate the impact of beta blocker administration among subjects undergoing transcatheter aortic valve replacement (TAVR).
Key facts
- Sponsor
- Universitaetsspital Basel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 4 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-07
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518731-11-00
- ClinicalTrials.gov
- NCT06472934
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The aim of the study is to investigate the impact of beta blocker administration among subjects undergoing transcatheter aortic valve replacement (TAVR).
Conditions and MedDRA coding
Aortic stenosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Informed Consent must be signed by the subject prior to any study intervention.
- Adult patients (› 18 years) with severe symptomatic aortic stenosis eligible and scheduled for elective TAVR and are able to give consent.
- Indication for B-blocker therapy with a prior treatment duration of at least 1 month before inclusion.
Exclusion criteria 13
- Emergency or urgent indication for TAVR.
- Hemodynamically unstable patients receiving inotropic medication.
- Prior permanent pacemaker implantation.
- Existing indication for pacemaker implantation.
- Hemodynamic relevant left ventricular outflow tract obstruction.
- Prior intolerance of B-blocker medication.
- Life expectancy ‹ 1 year.
- Known or suspected non-compliance, drug, or alcohol abuse.
- Inability to give consent, or follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Being in a dependent relationship with the trial site.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
- Previous enrolment into the current study.
- Pregnancy or breast feeding women.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Secondary endpoints 6
- Pacemaker Rate at 30 days and at 1 year
- Stroke Rate at 30 days and at 1 year
- All-cause mortality at 30 days and 1 year
- Cardiovascular mortality at 30 days and 1 year
- Re-hospitalization due to heart failure at 30 days and 1 year
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
-
C07AG · Product
- Pharmaceutical form
- PHF00009MIG
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- C07AG — ALPHA AND BETA BLOCKING AGENTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
C07BB · Product
- Pharmaceutical form
- PHF00082MIG
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- C07BB — BETA BLOCKING AGENTS, SELECTIVE, AND THIAZIDES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
C07AA · Product
- Pharmaceutical form
- PHF00082MIG
- Route of administration
- ORAL USE
- Max daily dose
- 640 mg milligram(s)
- Max total dose
- 3840 mg milligram(s)
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- C07AA — BETA BLOCKING AGENTS, NON-SELECTIVE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
C07AB · Product
- Pharmaceutical form
- PHF00082MIG
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 2400 mg milligram(s)
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- C07AB — BETA BLOCKING AGENTS, SELECTIVE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
C07BG · Product
- Pharmaceutical form
- PHF00082MIG
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- C07BG — ALPHA AND BETA BLOCKING AGENTS AND THIAZIDES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsspital Basel
- Sponsor organisation
- Universitaetsspital Basel
- Address
- Petersgraben 4
- City
- Basel
- Postcode
- 4031
- Country
- Switzerland
Scientific contact point
- Organisation
- Universitaetsspital Basel
- Contact name
- PD Dr. Thomas Nestelberger
Public contact point
- Organisation
- Universitaetsspital Basel
- Contact name
- PD Dr. Thomas Nestelberger
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 100 | 2 |
| Germany | Ongoing, recruiting | 300 | 5 |
| Rest of world
Switzerland
|
— | 300 | — |
Investigational sites
University Hospital Salzburg
University Clinic for Internal Medicine II, Cardiology, Müllner Hauptstrasse 48, 5020, Salzburg
Medical University of Graz, Department of Internal Medicine, University Heart Centre Graz
Department of Cardiology, Auenbruggerplatz 15, 8036, Graz
Universitaetsklinikum Schleswig-Holstein AöR
Campus Kiel, Department of Internal Medicine III, Cardiology, Angiology and Intensive Care, Arnold-Heller-Strasse 3, Brunswik, Kiel
University Medical Center Freiburg, University Heart Center
Deaprtment of Cardiology and Angiology, Südring 15, 79189, Bad Krozingen
Kerckhoff-Klinik GmbH
Department of Cardiology, Benekestrasse 2-8, 61231, Bad Nauheim
Herz- und Diabeteszentrum NRW Universitätsklinik, Ruhr-Universität Bochum
Clinic for General and Interventional Cardiology/Angiology, Georgstraße 11, 32545, Bad Oeynhausen
Universitaetsklinikum Giessen und Marburg GmbH
Department of Cardiology, Klinikstrasse 33, 35392, Giessen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-08-04 | 2025-08-29 | |||
| Germany | 2025-10-01 | 2025-10-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 20 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518731-11-00_redacted | 2.1 |
| Protocol (for publication) | D4_Patient facing documents Discharge Questionnaire | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Discharge Questionnaire | 1.0 |
| Protocol (for publication) | D4_Patient facing documents KCCQ12 | 1.1 |
| Protocol (for publication) | D4_Patient facing documents KCCQ12 | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults MUG_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults SALK_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_HDZNRW_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_IMUG_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_KKBN_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_UKFR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_UKSH_redacted | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carvedilol | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carvedilol and thiazid | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Metoprolol tartrate | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nebivolol and thiazid | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Propanolol | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis AT 2024-518731-11-00 | 2.1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-03 | Austria | Acceptable 2025-04-14
|
2025-07-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-16 | Acceptable 2025-04-14
|
2025-09-16 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-24 | Acceptable 2025-04-14
|
2026-04-24 |