Effect of Dapagliflozin on VT in Patients With Heart Failure.
Effect of Sodium-dependent Glucose Transporters 2 Inhibitor Dapagliflozin on Ventricular Arrhythmia in Patients With Heart Failure.
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 heart-failure
Started Nov 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedStudy Start
First participant enrolled
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2024
CompletedSeptember 22, 2022
September 1, 2022
2 years
June 15, 2022
September 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Number of ventricular tachycardia/fibrillation events recorded by ICD.
Number of ventricular tachycardia/fibrillation events recorded by ICD.
1 year
Secondary Outcomes (4)
QRS duration
1 year
QT and QTc interval variability
1 year
QTd
1 year
Tp-e
1 year
Study Arms (2)
Placebo group
PLACEBO COMPARATORDapagliflozin group
EXPERIMENTALInterventions
The experimental group received dapagliflozin (10 mg qd) for 1 year.
Eligibility Criteria
You may qualify if:
- patients received ICD therapy with HFrEF, including: ischemic cardiomyopathy, non-ischemic cardiomyopathy, LVEF ≤35% and optimized anti-HF therapy for at least 6 months.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 15, 2022
First Posted
September 22, 2022
Study Start
November 15, 2022
Primary Completion
November 15, 2024
Study Completion
November 15, 2024
Last Updated
September 22, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share