search
Back to results

Effect of Dapagliflozin on VT in Patients With Heart Failure.

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, dapagliflozin, ventricular arrhythmia, clinical randomized controlled trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients received ICD therapy with HFrEF, including: ischemic cardiomyopathy, non-ischemic cardiomyopathy, LVEF ≤35% and optimized anti-HF therapy for at least 6 months.

Exclusion Criteria:

  1. Type 1 diabetes or a history of repeated diabetic ketoacidosis.
  2. Those who strictly restrict carbohydrate intake.
  3. Genital infection.
  4. Low blood pressure.
  5. SGLT2i allergy.
  6. Severe renal impairment or end-stage renal disease (eGFR<30ml/(min•1.73m^2)) or dialysis.
  7. The water-electrolyte and acid-base balance disorders have not been corrected.
  8. Bladder cancer.
  9. Those taking other antiarrhythmic drugs except beta-blockers.
  10. Other diseases cause the patient's life expectancy to be less than 1 year.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo group

    Dapagliflozin group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of ICD discharges and mode of electrical therapy (ATP, synchronized cardioversion, electrical defibrillation)
    Number of ICD discharges and mode of electrical therapy (ATP, synchronized cardioversion, electrical defibrillation)
    Number of ventricular tachycardia/fibrillation events recorded by ICD.
    Number of ventricular tachycardia/fibrillation events recorded by ICD.

    Secondary Outcome Measures

    QRS duration
    QRS duration
    QT and QTc interval variability
    QT and QTc interval variability
    QTd
    The difference between the longest QT interval and the shortest QT interval in the ECG
    Tp-e
    Time from T wave apex to T wave end

    Full Information

    First Posted
    June 15, 2022
    Last Updated
    September 19, 2022
    Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05550441
    Brief Title
    Effect of Dapagliflozin on VT in Patients With Heart Failure.
    Official Title
    Effect of Sodium-dependent Glucose Transporters 2 Inhibitor Dapagliflozin on Ventricular Arrhythmia in Patients With Heart Failure.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2022 (Anticipated)
    Primary Completion Date
    November 15, 2024 (Anticipated)
    Study Completion Date
    November 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This project plans to design a randomized controlled clinical trial to evaluate the effect of dapagliflozin on ventricular arrhythmia in the participants with heart failure with reduced ejection fraction after ICD implantation by collecting and analyzing the data of ECG, cardiac ultrasound and ICD programming. This project will explore the anti-ventricular arrhythmia effect of dapagliflozin in HFrEF patients.
    Detailed Description
    This is a single-center, randomized, controlled, double-blind study in Chinese heart failure participants with ICD implantation. This trial aims to investigate the effect of dapagliflozin on ventricular arrhythmias in participants with HFrEF. This trial includes a screening period, a treatment period and a follow-up period. Total duration of each subject's participation in the trial is approximately 1 year. During the screening period, 120 participants with HFrEF with ICD implanted in the investigator's department were recruited. The participants should sign the informed consent and be randomly divided into 2 groups. All participants will receive the best anti-heart failure treatment for 6 months before enrollment, including ACEI/ARB/ARNI, β-blockers, spironolactone, diuretics, and digitalis. One group was randomized to receive dapagliflozin (10 mg qd) and another group received place. Participants were then enrolled in a 1-year clinical trial and investigators will record the participants' QT interval, QTc interval, frequency and mode of ICD electrical therapy, cardiac function, symptoms, signs and other indicators before and after treatment to evaluate the occurrence of ventricular arrhythmia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    heart failure, dapagliflozin, ventricular arrhythmia, clinical randomized controlled trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Title
    Dapagliflozin group
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Dapagliflozin
    Intervention Description
    The experimental group received dapagliflozin (10 mg qd) for 1 year.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    The Placebo group received placebo for 1 year.
    Primary Outcome Measure Information:
    Title
    Number of ICD discharges and mode of electrical therapy (ATP, synchronized cardioversion, electrical defibrillation)
    Description
    Number of ICD discharges and mode of electrical therapy (ATP, synchronized cardioversion, electrical defibrillation)
    Time Frame
    1 year
    Title
    Number of ventricular tachycardia/fibrillation events recorded by ICD.
    Description
    Number of ventricular tachycardia/fibrillation events recorded by ICD.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    QRS duration
    Description
    QRS duration
    Time Frame
    1 year
    Title
    QT and QTc interval variability
    Description
    QT and QTc interval variability
    Time Frame
    1 year
    Title
    QTd
    Description
    The difference between the longest QT interval and the shortest QT interval in the ECG
    Time Frame
    1 year
    Title
    Tp-e
    Description
    Time from T wave apex to T wave end
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients received ICD therapy with HFrEF, including: ischemic cardiomyopathy, non-ischemic cardiomyopathy, LVEF ≤35% and optimized anti-HF therapy for at least 6 months. Exclusion Criteria: Type 1 diabetes or a history of repeated diabetic ketoacidosis. Those who strictly restrict carbohydrate intake. Genital infection. Low blood pressure. SGLT2i allergy. Severe renal impairment or end-stage renal disease (eGFR<30ml/(min•1.73m^2)) or dialysis. The water-electrolyte and acid-base balance disorders have not been corrected. Bladder cancer. Those taking other antiarrhythmic drugs except beta-blockers. Other diseases cause the patient's life expectancy to be less than 1 year.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shuxian Zhou, Doctor
    Phone
    13501515156
    Email
    drzhousx@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Dapagliflozin on VT in Patients With Heart Failure.

    We'll reach out to this number within 24 hrs