Image

Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

Recruiting
18 years and older
All
Phase 4

Powered by AI

Overview

Atrial fibrillation (AF) is the most common arrhythmia, which leads to reduced cardiac output and promotes the occurrence of heart failure, and abnormal hemodynamic changes in the left atrium induce thrombosis, which seriously reduces the quality of life, and even leads to death. For patients who need cardiac surgery combined with the Cox-Maze IV (CMIV) surgical ablation, oral amiodarone postoperatively for three consecutive months was recommended as the preferred treatment option. However, the study found there were still 15%-35% of patients at risk of AF recurrence. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has been widely used for the treatment of type 2 diabetes mellitus and heart failure. Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF and reduces adverse cardiovascular events for patients who need CMIV ablation, and whether it can be routinely used for AF patients without diabetes or heart failure. Therefore, this study aims to explore the effect of postoperative oral dapagliflozin on the recurrence of AF after CMIV.

Eligibility

Inclusion Criteria:

  • Age ≥18 years
  • Patients with persistent or long-term persistent atrial fibrillation who need isolated surgical Cox-Maze IV procedure
  • Patients who need cardiac surgery combined with Cox-Maze IV procedure
  • Patients who have the ability and willingness to abide by all the subsequent reviews and requirements
  • Sign the informed consent

Exclusion Criteria:

  • Dapagliflozin allergy
  • Hyperthyroidism
  • Patients with acute myocardial infarction, cerebral apoplexy, and other vascular diseases during the past 6 months
  • Patients who received heart surgery within the last 3 months
  • eGFR<45ml/min
  • History of oral SGLT2i
  • Estimated survival period < 12 months
  • Pregnant and lactating women
  • Left atrial diameter > 65 mm
  • Refusing to sign the informed consent

Study details
    Atrial Fibrillation Recurrence
    Cox Maze IV
    Atrial Fibrillation
    Patients With or Without Heart Failure and Diabetes

NCT05816733

Kun Hua

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.