NCT06804161招募中3 期
SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension
Prof. Dr. med. Ingo Eitel1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年12月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Time until first occurrence of
研究概览
简要总结
Hypertension (HTN) is a leading cause of cardiovascular disease (CVD). Despite existing therapies, patients with HTN still face substantial risks, due to pre-existing and ongoing end-organ damage due, in part, to inadequate blood pressure (BP) control. SGLT2 inhibitors (SGLT2i) are recommended for both type-2 diabetes and heart failure to reduce morbidity and mortality. SGLT2i reduce BP and might also improve outcomes for HTN by reducing end-organ damage through diverse other actions. However, confirmation that SGLT2i are clinically useful for the management of HTN is required to change guidelines and clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years
- •Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg in two measurements on different days for newly diagnosed hypertension, or through one measurement at the screening visit for patients with an existing diagnosis of hypertension.
- •A history of at least one CV event (myocardial infarction* or stroke*; stable angina or clinical evidence of coronary heart disease; peripheral arterial disease; transient ischemic attack)
- •The presence of at least one cardiovascular risk factor (current smoking of more than one cigarette per day during at least 1 year; LDL-cholesterol > 4,0 mmol/l, Age ≥ 75 years, ESC HeartScore > 15%, BMI > 32 kg/m2)
- •*excluding patients with myocardial infarction or stroke within preceding 3 months
排除标准
- •Known secondary cause of hypertension
- •Myocardial infarction or stroke within the previous 3 months
- •Symptomatic heart failure (including HFrEF, HFmEF, HFpEF)
- •History of Diabetes mellitus
- •History of ketoacidosis
- •Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN])
- •eGFR <25 mL/min/1.73 m2 (CKD-EPICr 2021 formula) at Visit 1
- •Receiving therapy with an SGLT2i within 8 weeks prior to randomization or previous intolerance to an SGLT2i
- •Participation in another clinical study with an investigational product during the last month prior to enrolment
- •Known allergy or hypersensitivity to SGLT2i
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- •Any medical condition - outside the renal and CV disease area - with a life expectancy of less than 2 years based on investigator's clinical judgement
- •Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)
- •Inability to give informed consent
研究组 & 干预措施
SGLT2 Arm
Experimental
干预措施: SGLT2 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time until first occurrence of
时间窗: 7 Years
次要结局
未报告次要终点
研究者
Prof. Dr. med. Ingo Eitel
Head of department of medical clinic II
University of Luebeck
研究点 (1)
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