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

Primary Purpose

Atrial Fibrillation Recurrence, Cox Maze IV, Atrial Fibrillation

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
Kun Hua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation Recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Dapagliflozin group

    Placebo group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Rate of atrial fibrillation recurrence

    Secondary Outcome Measures

    Rate of atrial fibrillation recurrence
    Cardiovascular complex adverse events
    cardiogenic death, new onset heart failure, malignant arrhythmias, stroke

    Full Information

    First Posted
    April 2, 2023
    Last Updated
    April 16, 2023
    Sponsor
    Kun Hua
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05816733
    Brief Title
    Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure
    Acronym
    DETAIL-CMIV
    Official Title
    Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 7, 2023 (Anticipated)
    Primary Completion Date
    June 7, 2024 (Anticipated)
    Study Completion Date
    August 7, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kun Hua

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation Recurrence, Cox Maze IV, Atrial Fibrillation, Patients With or Without Heart Failure and Diabetes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    348 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dapagliflozin group
    Arm Type
    Experimental
    Arm Description
    Patients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Patients who will be randomized to receive placebo following the Cox-Maze IV Procedure.
    Intervention Type
    Drug
    Intervention Name(s)
    Dapagliflozin
    Intervention Description
    Patients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Patients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment.
    Primary Outcome Measure Information:
    Title
    Rate of atrial fibrillation recurrence
    Time Frame
    half of one year post operative
    Secondary Outcome Measure Information:
    Title
    Rate of atrial fibrillation recurrence
    Time Frame
    one year post operative
    Title
    Cardiovascular complex adverse events
    Description
    cardiogenic death, new onset heart failure, malignant arrhythmias, stroke
    Time Frame
    one year post operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhan Peng
    Phone
    010-64456776
    Email
    anzhen0607@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiubin Yang
    Phone
    010-64456776
    Email
    xiubinyang@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kun Hua
    Organizational Affiliation
    Beijing Anzhen Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

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