Clinical trial • Phase III • Cardiology

DAPAGLIFLOZIN PROPANEDIOL for Atrial fibrillation

Phase III trial of DAPAGLIFLOZIN PROPANEDIOL for Atrial fibrillation.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Atrial fibrillation
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
31-05-2024
First CTIS Authorization Date
14-08-2024

Trial design

Randomised, open-label, dapagliflozin (oral; max daily dose 10 mg indicated in product information) versus usual care-controlled Phase III trial across 7 sites in Sweden.

Randomised
Yes
Open Label
Yes
Comparator
Dapagliflozin (oral; max daily dose 10 mg indicated in product information) versus usual care
Real World Control
Yes
Target Sample Size
1600
Trial Duration For Participant
30

Eligibility

Recruits 1600 No vulnerable populations selected; written informed consent is required from participants..

Vulnerable Population
No vulnerable populations selected; written informed consent is required from participants.

Inclusion criteria

  • {"criterion_text":"- Patients with AF on ECG who are planned for electrical cardioversion within 7-26 from inclusion-date."}
  • {"criterion_text":"- Age ≥ 55 years."}
  • {"criterion_text":"- The subject has given their written consent to participate in the trial."}

Exclusion criteria

  • {"criterion_text":"- Current treatment with SGLT2 inhibitor (dapagliflozin, empagliflozin, canagliflozin, sotagliflozin)."}
  • {"criterion_text":"- Prior/current diagnosis of heart failure."}
  • {"criterion_text":"- Type 1 diabetes mellitus."}
  • {"criterion_text":"- Estimated glomerular filtration rate (eGFR) < 25 ml/min/1.73m2."}
  • {"criterion_text":"- Pulmonary vein isolation within last 3 months or planned pulmonary vein isolation within study period (56 days)."}
  • {"criterion_text":"- Contraindications to SGLT2 inhibitors (dapagliflozin, empagliflozin, canagliflozin, sotagliflozin)."}
  • {"criterion_text":"- Any condition or circumstance in which the patient should not participate in the study according to the study investigator."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time to recurrence of AF within 30 days after cardioversion.","definition_or_measurement_approach":"Time to recurrence of AF within 30 days after cardioversion (as stated)."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of patients in sinus rhythm (SR) 30 days after cardioversion.","definition_or_measurement_approach":"Proportion in sinus rhythm at 30 days after cardioversion (as stated)."}
  • {"endpoint_text":"- Proportion of patients without any AF recurrence at 30 days","definition_or_measurement_approach":"Proportion without any AF recurrence within 30 days (as stated)."}
  • {"endpoint_text":"- Time to spontaneous return to SR before electrical cardioversion.","definition_or_measurement_approach":"Time from inclusion to spontaneous return to sinus rhythm prior to planned electrical cardioversion (as stated)."}
  • {"endpoint_text":"- Spontaneous return to SR before cardioversion.","definition_or_measurement_approach":"Occurrence of spontaneous return to sinus rhythm before cardioversion (as stated)."}
  • {"endpoint_text":"- Success of cardioversion (discharged with SR).","definition_or_measurement_approach":"Successful cardioversion defined as discharge in sinus rhythm (as stated)."}
  • {"endpoint_text":"- Total number of days with AF recordings during 30 days following cardioversion.","definition_or_measurement_approach":"Count of days with AF recordings during the 30 days post-cardioversion period (as stated)."}
  • {"endpoint_text":"- Absence of clinical AF recurrence (12- lead ECG-verified) during follow-up after EC or after spontaneous return to SR (before EC).","definition_or_measurement_approach":"Absence of clinical AF recurrence confirmed by 12-lead ECG during follow-up (as stated)."}

Recruitment

Planned Sample Size
1600
Recruitment Window Months
41
Consent Approach
Written informed consent required from the participant ('The subject has given their written consent to participate in the trial.'). No paediatric assent/consent procedures or languages specified.

Geography

Total Number Of Sites
7
Total Number Of Participants
1600

Sweden

Earliest CTIS Part Ii Submission Date
27-07-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
18
Number Of Sites
7
Number Of Participants
1600

Sites

Site Name
Soedersjukhuset AB
Department Name
VO Kardiologi
Contact Person Name
Joakim Olbers
Site Name
Karolinska University Hospital
Department Name
Tema Hjärta-Kärl och Neuro, ME kardiologi
Contact Person Name
Karolina Szummer
Site Name
Region Oerebro Laen
Department Name
VO hjärt- lungmedicin och klinisk fysiologi, Universitetssjukhuset Örebro
Contact Person Name
Anna Björkenheim
Contact Person Email
etikansokan@regionorebrolan.se
Site Name
Uppsala University Hospital
Department Name
Kardiologkliniken
Contact Person Name
Ziad Hijazi
Site Name
Region Vaesterbotten
Department Name
Norrlands universitetssjukhus, Daniel Naezéns väg, 907 37 Umeå, Kardiologi
Contact Person Name
Ioannis Katsoularis
Site Name
Danderyds Sjukhus AB
Department Name
Hjärtkliniken
Contact Person Name
Johan Engdahl
Site Name
Region Oestergoetland
Department Name
Kardiologiska Kliniken
Contact Person Name
Lars Karlsson

Sponsor

Primary sponsor

Full Name
Karolinska University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
DAPAGLIFLOZIN
Active Substance
DAPAGLIFLOZIN PROPANEDIOL
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
10 mg

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