Empagliflozin as a Potential Therapeutic Solution for Patients With Brugada Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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:
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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.
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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.
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Undergo a series of check-ups and tests, including:
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12-lead electrocardiography (ECG) recordings.
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Monitoring and documentation of adverse events.
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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.
详细描述
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial protocol The initial dose will start at 10 mg empagliflozin once a day, with monthly follow-ups for dose titration based on ECG ST-segment morphology done in lead V1, V2 at 4th, 3rd and 2nd intercostal spaces (ICSs). Responder is defined as any one of lead with a decrease in J-point elevation ≥1 mm from baseline. Responders will continue receiving 10 mg empagliflozin once a day, while non-responders will have their dose increased to 25 mg once a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Empagliflozin
干预措施: Empagliflozin (EMPA) (Drug)
结局指标
主要结局
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
时间窗: From enrollment to the end of treatment at 8 weeks
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.
次要结局
未报告次要终点