Effect of Sodium-dependent Glucose Transporters 2 Inhibitor Dapagliflozin on Ventricular Arrhythmia in Patients With Heart Failure.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Number of ICD discharges and mode of electrical therapy (ATP, synchronized cardioversion, electrical defibrillation)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients received ICD therapy with HFrEF, including: ischemic cardiomyopathy, non-ischemic cardiomyopathy, LVEF ≤35% and optimized anti-HF therapy for at least 6 months.
排除标准
- •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.
研究组 & 干预措施
Placebo group
干预措施: Placebo (Drug)
Dapagliflozin group
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Number of ICD discharges and mode of electrical therapy (ATP, synchronized cardioversion, electrical defibrillation)
时间窗: 1 year
Number of ICD discharges and mode of electrical therapy (ATP, synchronized cardioversion, electrical defibrillation)
Number of ventricular tachycardia/fibrillation events recorded by ICD.
时间窗: 1 year
Number of ventricular tachycardia/fibrillation events recorded by ICD.
次要结局
- QRS duration(1 year)
- QTd(1 year)
- Tp-e(1 year)
- QT and QTc interval variability(1 year)
研究者
Shuxian Zhou
Clinical Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University