Effect of Dapagliflozin on VT in Patients With Heart Failure.

NCT ID: NCT05550441

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-11-15

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The Placebo group received placebo for 1 year.

Dapagliflozin group

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

The experimental group received dapagliflozin (10 mg qd) for 1 year.

Interventions

Dapagliflozin

The experimental group received dapagliflozin (10 mg qd) for 1 year.

Intervention Type: DRUG

Placebo

The Placebo group received placebo for 1 year.

Intervention Type: DRUG

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Shuxian Zhou

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Shuxian Zhou, Doctor

Role: CONTACT

drzhousx@163.com

13501515156

Other Identifiers

2020-KY-129

Identifier Type: -

Identifier Source: org_study_id