Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Shuxian Zhou
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.
Heart Failure
Dapagliflozin
Placebo
Phase 4
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.
Study Type : | Interventional |
Estimated Enrollment : | 120 participants |
Masking: | Quadruple |
Primary Purpose: | Treatment |
Official Title: | Effect of Sodium-dependent Glucose Transporters 2 Inhibitor Dapagliflozin on Ventricular Arrhythmia in Patients With Heart Failure. |
Actual Study Start Date : | November 15, 2022 |
Estimated Primary Completion Date : | November 15, 2024 |
Estimated Study Completion Date : | November 15, 2024 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo group |
Drug: Placebo |
Experimental: Dapagliflozin group |
Drug: Dapagliflozin |
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.