The goal of this clinical trial is to learn if Empagliflozin works to treat Brugada syndrome patients by affecting their electrocardiographic (ECG) patterns, and to evaluate its safety.
The main questions it aims to answer are:
* Does Empagliflozin improve specific electrocardiogram (ECG) patterns in Brugada syndrome patients, specifically by observing the change in J-point elevation recorded in V1 and V2 leads at the 4th, 3rd, and 2nd intercostal spaces (ICSs)? A responder is defined as a decrease in J-point elevation of ≥1 mm. * What adverse events do participants experience when taking Empagliflozin, including hypotension, acute renal failure, hepatic injury, ketoacidosis, hypoglycemic events, urinary tract infections, genital infections, bone fractures, and events leading to lower limb amputation?
Researchers will compare each participant's ECG changes before and after three months of Empagliflozin treatment to assess its efficacy
Participants will:
* Take Empagliflozin once daily, starting at 10 mg. The dose will be increased to 25 mg at monthly follow-ups if participants are non-responders based on ECG ST-segment morphology. The total treatment period is three months. * Visit the outpatient clinic monthly for three months of treatment to monitor efficacy and safety. The overall trial period, including screening, treatment, and follow-up, comprises five scheduled visits. * Undergo a series of check-ups and tests, including:
* 12-lead electrocardiography (ECG) recordings. * Monitoring and documentation of adverse events. * Blood and urine tests, such as complete blood count (CBC), liver function tests (AST/ALT), renal function tests (BUN/creatinine), electrolytes (sodium/potassium/calcium/magnesium/albumin), urinalysis, fasting glucose, HbA1c, and ketone measurements.
Patients diagnosed with Brugada syndrome and aged 18-99 years with spontaneous type 1 ECG, normal structural heart and patent coronary artery
Obtain written informed consent for participation in the clinical trial
Individuals with type 1 ECG pattern only observed with fever-induced or drug-induced were excluded from this exploratory study.
Current or prior use of an SGLT2 inhibitor within 12 weeks before screening or randomization
Known allergy or hypersensitivity to any SGLT2 inhibitor
History of ketoacidosis
Single group
Empagliflozin (EMPA)
DrugParticipants will take Empagliflozin once daily, starting at 10 mg. The dose will be increased to 25 mg at monthly follow-ups if participants are non-responders based on ECG ST-segment morphology. The total treatment period is three months.
Maximal change of type 1 Brugada pattern (defined as maximal J point deviation minus baseline J point hight) recording with 12-lead electrocardiogram within lead V1 and V2 in 4th, 3rd, and 2nd ICSs
Maximal Change of type 1 Brugada pattern (Coved ST segment elevation \>2mm in \>1 of V1-V3 followed by a negative T wave.) is defined as maximal J point deviation minus baseline J point elevation in the same leads. The responder is defined as decreased ≥ 1mm of J point in any one of above 6 leads.
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
Adverse event (AE) will be monitored as trail protocol. Adverse event including hypotension, symptomatic hypotension, acute renal failure, hepatic injury, ketoacidosis, hypoglycemic events, urinary tract infections, genital infections, bone fractures, events leading to lower limb amputation.
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National Taiwan University Hospital
Lead sponsor
Stanford University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
