Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

Atrial Fibrillation Clinical Trial

— DETAIL-CMIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816733
• Other study ID #: KS2023017
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2023
• Est. completion date: August 7, 2024

Study information

• Verified date: November 2023
• Source: Beijing Anzhen Hospital
• Contact: Zhan Peng
• Phone: 010-64456776
• Email: anzhen0607[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. completion date: August 7, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Recurrence
• Recurrence

Intervention

Drug:
• Dapagliflozin
Patients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment.
• Placebo
Patients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment.

Locations

Country	Name	City	State
China	Cardiac Surgery Center No. 7	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Kun Hua

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of atrial fibrillation recurrence		half of one year post operative
Secondary	Rate of atrial fibrillation recurrence		one year post operative
Secondary	Cardiovascular complex adverse events	cardiogenic death, new onset heart failure, malignant arrhythmias, stroke	one year post operative