Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure (DETAIL-CMIV)

Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Atrial Fibrillation Recurrence; Cox Maze IV; Patients With or Without Heart Failure and Diabetes
• Intervention / Treatment: Drug: Dapagliflozin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 348
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhan Peng; Phone Number: 010-64456776; Email: anzhen0607@126.com
• Study Contact Backup: Name: Xiubin Yang; Phone Number: 010-64456776; Email: xiubinyang@yahoo.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Cardiac Surgery Center No. 7
      • Contact: zhan peng; Phone Number: 01064456776; Email: anzhen0607@126.com
      • Principal Investigator: Hua Kun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapagliflozin group; Patients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure.	Drug: Dapagliflozin; Patients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment.
Placebo Comparator: Placebo group; Patients who will be randomized to receive placebo following the Cox-Maze IV Procedure.	Drug: Placebo; Patients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of atrial fibrillation recurrence	half of one year post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of atrial fibrillation recurrence		one year post operative
Cardiovascular complex adverse events	cardiogenic death, new onset heart failure, malignant arrhythmias, stroke	one year post operative

Collaborators and Investigators

• Sponsor: Kun Hua
• Investigators: Study Director: Kun Hua, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): June 7, 2024
• Study Completion (Estimated): August 7, 2024

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: KS2023017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No