Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

NCT05816733 | Unknown Phase 4

• 1 other identifier: KS2023017
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Rate of atrial fibrillation recurrence

  half of one year post operative

Secondary Outcomes (2)

• Rate of atrial fibrillation recurrence

  one year post operative

• Cardiovascular complex adverse events

  one year post operative

Study Arms (2)

Dapagliflozin group

EXPERIMENTAL

Patients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure.

Drug: Dapagliflozin

Placebo group

PLACEBO COMPARATOR

Patients who will be randomized to receive placebo following the Cox-Maze IV Procedure.

Drug: Placebo

Interventions

Dapagliflozin DRUG

Patients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment.

Dapagliflozin group

Placebo DRUG

Patients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kun Hua: lead

Study Sites (1)

Cardiac Surgery Center No. 7

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kun Hua

  Beijing Anzhen Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhan Peng

CONTACT

010-64456776; anzhen0607@126.com

Xiubin Yang

CONTACT

010-64456776; xiubinyang@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: April 18, 2023
• Study Start: September 1, 2023
• Primary Completion: June 7, 2024
• Study Completion: August 7, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CN (1)