Overview
Sponsor-declared trial summary
Aortic stenosis
The purpose of this trial is to test whether SGLT2 inhibition after AVR is superior to placebo in reducing left ventricular mass and improve patient symptoms.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 7 Feb 2024 → 8 May 2026
- Decision date (initial)
- 2023-11-08
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The purpose of this trial is to test whether SGLT2 inhibition after AVR is superior to placebo in reducing left ventricular mass and improve patient symptoms.
Conditions and MedDRA coding
Aortic stenosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10002916 | Aortic valve replacement | 100000004865 |
| 20.1 | PT | 10002906 | Aortic stenosis | 100000004866 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504731-40-00 | EMPagliflozin after Aortic Valve Replacement - the EMPAVR study - a randomized clinical trial | Rigshospitalet |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Severe symptomatic AS AND Surgical or transcatheter AVR within 14 days
Exclusion criteria 4
- Prior treatment with an SGLT2i
- LVEF <45%
- eGFR <30ml/min
- Hypersensitivity to empagliflozin or placebo tablet
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in left ventricular mass indexed to body surface area (measured by CT) from pre aortic valve replacement (AVR) to 12-months post-AVR
Secondary endpoints 4
- Left ventricular end-systolic volume indexed to body surface are (LVESVi measured by CT)
- Left ventricular global longitudinal strain (LV GLS) (measured by echo)
- NT-proBNP change from baseline to 12 months
- Composite of death and readmission for any non-planned cause
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Jardiance 10 mg film-coated tablets
PRD1594848 · Product
- Active substance
- Empagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BK03 — -
- Marketing authorisation
- EU/1/14/930/010
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Glucosemonohydrate with HPMC capsule
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Emil Fosbøl
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Emil Fosbøl
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 206 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Denmark | 2024-02-07 | 2026-05-08 | 2024-02-07 | 2025-11-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | KCCQ12 | 1 |
| Protocol (for publication) | MLHFQ | 1 |
| Protocol (for publication) | PROTOCOL | 5 |
| Protocol (for publication) | PROTOCOL TRACK CHANGES | 3 |
| Recruitment arrangements (for publication) | RECRUITMENT ARRANGEMENTS | 1 |
| Subject information and informed consent form (for publication) | INFORMED CONSENT FORM | 5 |
| Subject information and informed consent form (for publication) | INFORMED CONSENT FORM track changes | 5 |
| Subject information and informed consent form (for publication) | SUBJECT INFORMATION | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | SMPC JARDIANCE | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-24 | Denmark | Acceptable 2023-11-03
|
2023-11-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-12 | Denmark | Acceptable 2024-03-20
|
2024-03-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-21 | Denmark | Acceptable 2024-07-19
|
2024-07-22 |