Effect of empagliflozin on ventricular arrhythmias

Phase 3

Conditions: Ventricular arrhythmia.
Re-entry ventricular arrhythmia
I47.0

Registration Number: IRCT20120520009801N7

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 72

Inclusion Criteria

Age older than 18 years old
Heart failure diagnosis
ICD implantation > three months before eligibility test
Signed, written informed consent to participate in the study

Exclusion Criteria

Patients using empagliflozin or other SGLT2 inhibitors before the eligibility test
New York Heart Association Class IV heart failure
Renal dysfunction (eGFR < 30 mL/min/1.73 m2 or dialysis)
Hepatic dysfunction (liver function test > 3 times higher than upper limit of normal)
Body mass index < 18.5 kg/m2
Pregnant or suspected pregnancy
Patients with the following events within 3 months before the eligibility test: alteration of antiarrhythmic drug, catheter ablation for ventricular arrhythmia, coronary revascularization, open-heart surgery, development of coronary artery disease, stroke or transient ischemic stroke, seizure, infection requiring hospitalization, heart failure requiring hospitalization
Other comorbidities including various infections, major surgery, type 1 diabetes, pituitary or adrenal insufficiency, malnutrition, drug or alcohol abuse or dependence, gastrointestinal diseases, cancer
ICDs unable to record cardiac arrhythmias

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of the ventricular arrhythmias (PVC, NSVT, VT, VF). Timepoint: During the three months before the intervention and along the three months of the intervention. Method of measurement: ICD (implantable cardioverter-defibrillator) record.

Secondary Outcome Measures

Name	Time	Method
Hospitalization. Timepoint: During the three months before the intervention and along the three months of the intervention. Method of measurement: Questionnaire.;Functional class of heart failure. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Clinical examination and questionnaire.;Peripheral edema. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Clinical examination and scale.;Oxygen saturation of the arterial blood (SaO2). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Pulse oximeter device.;Blood glucose. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Laboratory.;Blood pressure. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Sphygmomanometer.;Lipid profile. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Laboratory.