Empagliflozin as a Potential Therapeutic Solution for Patients With Brugada Syndrome

Sponsor
National Taiwan University Hospital
Study ID
NCT07146880
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Brugada Syndrome (BrS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin (EMPA) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 15, 2025
Status verified
Aug 2025
Primary completion
Aug 21, 2027
Completion
Sep 21, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin

Primary Outcome Measure

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 [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

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