RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Dapagliflozin or Usual Care

Официальное название

RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Open-label Treatment With Dapagliflozin or Usual Care

Обзор

The goal of this clinical trial is to learn if drug dapagliflozin, a sodium-glucose transport-2 inhibitor, works to treat atrial fibrillation in adults. The main question it aims to answer is: • Does the drug dapagliflozin reduce the recurrence rate of atrial fibrillation? Researchers will compare drug dapagliflozin to standard therapy to see if drug dapagliflozin reduce the recurrence of atrial fibrillation. Persons with atrial fibrillation who are planned for an electric cardioversion will: * Take the drug dapagliflozin, or no drug, once a day for a maximum of 56 days * Undergo a planned electric cardioversion of the atrial fibrillation * Record the rhythm with a hand-held device that transmits the signal to researchers during the study period, but no longer than for 56 days

Вмешательства

• Препарат Dapagliflozin 10 mg once daily
  Tablet Dapagliflozin 10 mg orally during from randomization for maximum 56 days.

Первичные конечные точки

• Atrial fibrillation recurrence [Срок оценки: 30 days after elective electrical cardioversion]

Вторичные конечные точки (7)

• Proportion of patients in SR at 30 days [Срок оценки: 30 days after elective electrical cardioversion]
• Proportion of patients without any atrial fibrillation recurrence at 30 days [Срок оценки: 30 days after elective electrical cardioversion]
• Time to spontaneous return to sinus rhythm before electrical cardioversion [Срок оценки: Up to 26 days]
• Spontaneous return to sinus rhythm before cardioversion. [Срок оценки: Up to 26 days]
• Success of cardioversion [Срок оценки: Periprocedural]
• Total number of days with atrial fibrillation [Срок оценки: From day of electric cardioversion to 30 days after]
• Absence of clinical atrial fibrillation recording [Срок оценки: From randomization to 30 days after electric cardioversion]

Критерии участия

Критерии включения

• Patients with AF on ECG who are planned for electrical cardioversion within 7-26 days from inclusion-date.
• Age ≥ 55 years.
• Provided written informed consent.

Критерии исключения

• Current treatment with an SGLT2 inhibitor.
• Prior/current diagnosis of heart failure.
• Type 1 diabetes mellitus.
• Estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73m2.
• Pulmonary vein isolation within preceding 3 months or planned pulmonary vein isolation during the study period (56 days).
• Contraindications to SGLT2 inhibitors.
• Any condition or circumstance in which the patient should not participate in the study according to the study investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Швеция · 7 центров

• Linköping university hosptial — Linköping
• Örebro University hospital — Örebro
• Södersjukhuset — Stockholm
• Karolinska University Hospital — Stockholm
• Danderyds Hospital — Stockholm
• Norrlands universitetssjukhus — Umeå
• Akademiska sjukhuset — Uppsala

Идентификаторы

NCT: NCT07187570 · EU CT 2024-513719-28-00 · 2024-513719-28-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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