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Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

NCT ID: NCT05816733

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-08-07

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dapagliflozin group

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

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Dapagliflozin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kun Hua

OTHER

Sponsor Role lead

Responsible Party

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Kun Hua

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kun Hua

Role: STUDY_DIRECTOR

Beijing Anzhen Hospital

Locations

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Cardiac Surgery Center No. 7

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhan Peng

Role: CONTACT

Phone: 010-64456776

Email: [email protected]

Xiubin Yang

Role: CONTACT

Phone: 010-64456776

Email: [email protected]

Facility Contacts

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zhan peng

Role: primary

Other Identifiers

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KS2023017

Identifier Type: -

Identifier Source: org_study_id