Effects and Mechanism of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change of left atrial volume index
研究概览
简要总结
In this multicenter, randomized, placebo-controlled trial in pre-heat failure patients with hypertension and without diabetes, we will enroll 120 eligible patients to randomized to receive placebo or engagliflozin (10mg/d) for follow them for 6 months. The primary endpoint is the left atrial volume index, which reflects left ventricular diastolic function. We sought to comprehensively evaluate the effect of engagliflozin on the structure and function and explore its underlying mechanisms.
详细描述
Hypertension is the leading risk factor of heart failure with preserved heart failure. The overall control rate is about 16% in China. Given the large amounts of hypertensive patients at pre-heart failure (stage B), it's critical to explore the effect of additional cardioprotective medication in addition to well-controlled blood pressure. Sodium-glucose cotransporter-2 inhibitors (engagliflozin) have been shown to improve cardiac function or prognosis in patients with diabetes or heart failure. However, whether it has a cardioprotective effect on hypertensive patients with pre-heart failure and without diabetes remains unknown. We will conduct a multicenter, randomized, placebo-controlled trial in pre-heat failure patients with hypertension and without diabetes. We will enroll 120 eligible patients randomized to receive a placebo or engagliflozin (10mg/d) for follow them for 6 months. The primary endpoint is the left atrial volume index, which reflects left ventricular diastolic function. The secondary endpoints include echocardiography or magnetic resonance imaging to measure structural and functional parameters, blood pressure, glucose, and blood biomarkers of inflammation and fibrosis. We sought to comprehensively evaluate the effect of empagliflozin on the structure and function and explore the underlying mechanisms to provide insights and evidence for the prevention of heart failure in hypertensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting all the following criteria:
- •Aged 18 years and above.
- •Hypertensive patients currently taking at least one antihypertensive medication as recommended by guidelines, and blood pressure is within the target range (<140/90 mmHg).
- •Within 3 months prior to screening，result meet any of the following criteria:
- •Left atrial volume index > 34 mL/m² measured by echocardiography;
- •Average E/e' > 9 measured by echocardiography;
- •NT-proBNP > 125 ng/ml.
- •Signing an informed consent form.
排除标准
- •• Exclusion criteria include any of the following conditions:
- •History of diabetes.
- •History of heart failure.
- •History of myocardial infarction, acute coronary syndrome within the past 6 months, or planned coronary revascularization within the next 6 months
- •Left ventricular systolic dysfunction, defined as LVEF < 50%.
- •Systolic blood pressure < 100 mmHg.
- •A history of arrhythmias such as atrial fibrillation, atrial flutter, frequent atrial premature contractions, and frequent ventricular premature contractions may impact the structural and functional aspects of the heart.
- •Moderate and above valvular heart disease.
- •Severe obstructive disease of the left ventricular outflow tract, including aortic valve stenosis.
- •Confirmed diagnosis of cardiomyopathy and infiltrative myocardial diseases.
- •Visited within the past 1 month due to Genitourinary tract infection.
- •Chronic kidney disease or estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73m².
- •Alanine aminotransferase or aspartate aminotransferase levels > 3 times the upper limit of normal.
- •Contraindications to taking SGLT2 inhibitors.
- •Currently taking SGLT2 inhibitors, SGLT-1/2 inhibitors, or other antihyperglycemic medications (including metformin, glucagon-like peptide-1 receptor agonists, etc.).
- •Pregnancy or planning pregnant, or currently breastfeeding.
- •Malignant tumors or other severe illnesses with a life expectancy of less than 3 years.
- •History of alcohol abuse or substance abuse within the past year.
- •Mental disorders or communication barriers, cognitive impairments, or other severe illnesses that may affect participation in the study.
- •Participation in or currently participating in other clinical trials within the last 3 months.
- •Known poor compliance with study follow-up or study drug.
- •Any condition or contraindication that makes a person intolerant to magnetic resonance imaging (MRI) or contraindicates MRI examination, such as the presence of implanted intracranial aneurysm clips, cardiac pacemakers or defibrillators, insulin pumps, etc.
研究组 & 干预措施
Empagliflozin
干预措施: Empagliflozin 10 MG (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change of left atrial volume index
时间窗: 6 months
Changes in Left Atrial Volume Index (LAVI, mL/m2) as measured by MRI from baseline to 6 months.
次要结局
- Change of cardiac structure and functional(6 months)
- Biomarkers(6 months)
- Estimated Glomerular Filtration Rate (eGFR)(6 months)