Effect of Dapagliflozin on VT in Patients With Heart Failure.

Heart Failure Clinical Trial

Official title:

Effect of Sodium-dependent Glucose Transporters 2 Inhibitor Dapagliflozin on Ventricular Arrhythmia in Patients With Heart Failure.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05550441
• Other study ID #: 2020-KY-129
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 15, 2022
• Est. completion date: November 15, 2024

Study information

• Verified date: September 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Shuxian Zhou, Doctor
• Phone: 13501515156
• Email: drzhousx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Dapagliflozin
The experimental group received dapagliflozin (10 mg qd) for 1 year.
• Placebo
The Placebo group received placebo for 1 year.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year
Primary	Number of ventricular tachycardia/fibrillation events recorded by ICD.	Number of ventricular tachycardia/fibrillation events recorded by ICD.	1 year
Secondary	QRS duration	QRS duration	1 year
Secondary	QT and QTc interval variability	QT and QTc interval variability	1 year
Secondary	QTd	The difference between the longest QT interval and the shortest QT interval in the ECG	1 year
Secondary	Tp-e	Time from T wave apex to T wave end	1 year