Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruiting
Participants planned
1,600
Countries
1
Sites
7
Atrial fibrillation
The main objective is to evaluate whether treatment with dapagliflozin, compared to usual care, prolongs the time to atrial fibrillation recurrence within 30 days after cardioversion.
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 4 Jun 2025 → ongoing
- Decision date (initial)
- 2024-08-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
The main objective is to evaluate whether treatment with dapagliflozin, compared to usual care, prolongs the time to atrial fibrillation recurrence within 30 days after cardioversion.
Secondary objectives 1
- To evaluate the atrial fibrillation burden after cardioversion, the need for repeat cardioversions, success of cardioversion, spontaneous return to sinus rhythm. Additional objectives are to study mechanisms of drug.
Conditions and MedDRA coding
Atrial fibrillation
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients with AF on ECG who are planned for electrical cardioversion within 7-26 from inclusion-date.
- Age ≥ 55 years.
- The subject has given their written consent to participate in the trial.
Exclusion criteria 7
- Current treatment with SGLT2 inhibitor (dapagliflozin, empagliflozin, canagliflozin, sotagliflozin).
- Prior/current diagnosis of heart failure.
- Type 1 diabetes mellitus.
- Estimated glomerular filtration rate (eGFR) < 25 ml/min/1.73m2.
- Pulmonary vein isolation within last 3 months or planned pulmonary vein isolation within study period (56 days).
- Contraindications to SGLT2 inhibitors (dapagliflozin, empagliflozin, canagliflozin, sotagliflozin).
- Any condition or circumstance in which the patient should not participate in the study according to the study investigator.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to recurrence of AF within 30 days after cardioversion.
Secondary endpoints 7
- Proportion of patients in sinus rhythm (SR) 30 days after cardioversion.
- Proportion of patients without any AF recurrence at 30 days
- Time to spontaneous return to SR before electrical cardioversion.
- Spontaneous return to SR before cardioversion.
- Success of cardioversion (discharged with SR).
- Total number of days with AF recordings during 30 days following cardioversion.
- Absence of clinical AF recurrence (12- lead ECG-verified) during follow-up after EC or after spontaneous return to SR (before EC).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP100377942 · ATC
- Active substance
- Dapagliflozin Propanediol
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 560 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BK01 — DAPAGLIFLOZIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Halsovagen, Flemingsberg Flemingsberg
- City
- Huddinge
- Postcode
- 141 86
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Tema Hjärta-Kärl och Neuro, ME kardiologi
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Tema Hjärta-Kärl och Neuro, ME kardiologi
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 1,600 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Karolinska University Hospital
Tema Hjärta-Kärl och Neuro, ME kardiologi, Halsovagen, Flemingsberg, Huddinge
Danderyds Sjukhus AB
Hjärtkliniken, Morbygardsvagen 88, 182 88, Danderyd
Soedersjukhuset AB
VO Kardiologi, Sjukhusbacken 10, Hogalid, Stockholm
Region Vaesterbotten
Norrlands universitetssjukhus, Daniel Naezéns väg, 907 37 Umeå, Kardiologi, Koksvagen 11, Alidhem, Umea
Region Oestergoetland
Kardiologiska Kliniken, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Region Oerebro Laen
VO hjärt- lungmedicin och klinisk fysiologi, Universitetssjukhuset Örebro, Sodra Grev Rosengatan, 701 85, Orebro
Uppsala University Hospital
Kardiologkliniken, Akademiska Sjukhuset, 751 85, Uppsala
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 |
|---|---|---|---|---|---|
| Sweden | 2025-06-04 | 2025-06-04 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | Sweden | Acceptable 2024-08-14
|
2024-08-14 |