Empagliflozin as a Potential Therapeutic Solution for Patients With Brugada Syndrome

NCT07146880 | Not Yet Recruiting Phase 2

• 1 other identifier: 202506158MINB
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brugada Syndrome (BrS)

Keywords

Brugada Syndrome (BrS); Sodium-glucose cotransporter 2 inhibitors (SGLT-2i); Empaflifozin

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 8 weeks

Other Outcomes (1)

• Incidence of Treatment-Related Adverse Events (Safety and Tolerability)

  From enrollment to the end of tial at 12 weeks

Study Arms (1)

Empagliflozin

EXPERIMENTAL

Drug: Empagliflozin (EMPA)

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.

Empagliflozin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Symptomatic hypotension or systolic blood pressure \<90 mmHg or \>180 mmHg
• Heart failure
• Acute myocardial infarction
• ALT or AST \>3× ULN at screening
• Impaired renal function (eGFR \<20 mL/min/1.73 m² \[MDRD\]), requiring dialysis, or functioning kidney transplant at screening
• Pregnancy, nursing, or planning pregnancy during the trial
• Enrollment in another investigational drug or device study or completion of such a study within the last 30 days
• Known poor adherence to clinic visits or prescribed medications
• Medical conditions that may limit trial participation, including severe respiratory disease, history of cancer with metastasis in the past four years (excluding non-melanoma skin cancer), or recent alcohol/substance misuse

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Stanford University: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Brugada Syndrome

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joseph Wu, MD, Phd

  Stanford University

  PRINCIPAL INVESTIGATOR

• JYH-MING JIMMY JUANG, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JYH-MING JIMMY JUANG, MD/PhD

CONTACT

+886-972651396; jjmjuang@gmail.com

HSINYU TSENG, MD

CONTACT

+886-972654628; b97401042@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 21, 2027
• Study Completion (Estimated): September 21, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)