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
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
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.
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
NCT ID
NCT05550441
First Posted
June 15, 2022
Last Updated
September 19, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
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Effect of Dapagliflozin on VT in Patients With Heart Failure.
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