Overview
Sponsor-declared trial summary
Cardiac-surgery associated acute kidney injury
The primary aim of the VERTIGO trial is to evaluate whether once daily perioperative empagliflozin reduces the incidence of acute kidney injury, compared with placebo, in patients requiring elective cardiac surgery with extracorporeal circulation.
Key facts
- Sponsor
- Hospital Clinico Universitario De Valladolid
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2025-01-16
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519997-37-00
- EudraCT number
- 2021-004938-11
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Therapy
The primary aim of the VERTIGO trial is to evaluate whether once daily perioperative empagliflozin reduces the incidence of acute kidney injury, compared with placebo, in patients requiring elective cardiac surgery with extracorporeal circulation.
Conditions and MedDRA coding
Cardiac-surgery associated acute kidney injury
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10017501 | Functional disturbances following cardiac surgery | 10022117 |
| 26.0 | PT | 10069339 | Acute kidney injury | 100000004857 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1) ≥18 years of age; 2) Requiring elective cardiac surgery with ECC; 3) Able to understand the aim of the study and to provide written informed consent
Exclusion criteria 1
- 1) Emergent surgery; 2) Endocarditis; 3) Patients awaiting heart transplantation; 4) Planned use of intra-aortic balloon pump; 5) Type 1 diabetes; 6) Chronic kidney disease with eGFR <30 mL/min/1.73 m2; 7) Severe liver dysfunction (ALT or AST >3 times above the upper limit of normality); 8) Active cancer; 9) Active treatment with any SGLT2i; 10) Known allergy to empagliflozin, any other SGLT2i or any of its excipients; 11) Solid organ transplant recipients; 12) Pregnant or lactating women; 13) Patients who are participating in another clinical trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Composite endpoint of worsening of renal function, defined as a decline in estimated glomerular filtration rate (eGFR) of ≥25%, renal replacement therapy initiation or death during the first 90 days following surgery
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Jardiance 10 mg film-coated tablets
PRD1594865 · Product
- Active substance
- Empagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 13 Day(s)
- Authorisation status
- Authorised
- ATC code
- A10BK03 — -
- Marketing authorisation
- EU/1/14/930/014
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The IMP has been repackaged so that there is no difference in the packaging compared to the placebo.
Comparator 1
SUB12626MIG · Substance
- Active substance
- Microcrystalline Cellulose
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 13 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Each film-coated tablet includes 248.75 mg of mycrocristalline cellulose
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Clinico Universitario De Valladolid
- Sponsor organisation
- Hospital Clinico Universitario De Valladolid
- Address
- Avenida Ramon Y Cajal 3
- City
- Valladolid
- Postcode
- 47003
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Clinico Universitario De Valladolid
- Contact name
- Armando Coca
Public contact point
- Organisation
- Hospital Clinico Universitario De Valladolid
- Contact name
- Armando Coca
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 608 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Study Protocol 3 | 3 |
| Recruitment arrangements (for publication) | Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | CEIm CONSENTIMIENTO INFORMADO CON MUESTRAS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Description_and_Composition | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-09 | Spain | Acceptable 2025-01-16
|
2025-01-16 |