Impact of Henagliflozin on Cardiac Structure, Function and Biomarkers of Heart Failure in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in left atrial minimal volume index
研究概览
简要总结
The HENA-AF trial will evaluate the effects of henagliflozin on cardiac structure, function, and biomarkers of HF in patients with AF. Participants with persistent AF, enlarged left atrium, and at least another cardiovascular risk factor will be randomized to henagliflozin or placebo. Cardiac MRI will be performed at baseline and at 6 months to measure the changes in cardiac structure and function. The primary hypothesis is that henagliflozin will reduce the left atrial volume index at 6 months in patients with AF.
详细描述
Atrial fibrillation (AF) is a major public health burden worldwide. Heart failure (HF) is one of the most common causes of death in patients with AF. Clinical trials have indicated that SGLT2i can reduce the risk of AF and HF in patients with diabetes, and improve the prognosis in patients with HF. However, whether SGLT2i can improve cardiac function and reduce the risk of HF in patients with AF remains unclear. The purpose of the HENA-AF trial is to evaluate the effects of henagliflozin on cardiac structure, function, and biomarkers of HF in patients with AF.
The HENA-AF trial will include approximately 100 persistent AF patients with enlarged left atrium and at least another cardiovascular risk factor. Participants will be randomized to henagliflozin or placebo. Cardiac MRI will be performed at baseline and at 6 months to measure the changes in cardiac structure and function. The primary hypothesis is that henagliflozin will reduce the left atrial volume index at 6 months in patients with AF.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 and ≤80 years old
- •Persistent AF: ECG or Holter diagnosed AF for more than 1 month
- •LA enlargement (LAAPD ≥40mm and <60mm)
- •One or more risk factors as follows: (1) ≥65 years old; (2) LVH: echocardiographic calculation of left ventricular mass index (LVMI) male ≥115g/m2; female ≥95g/m2 (LVMI=LVM/BSA,LVM=1.04 × [(LVID+IVST+LVPWT) 3-LVID3] * 0.8 * 0.6) BSA (m2) =0.0061 * height (cm) + 0.0128 * weight (kg)-0.1529; (3) Coronary heart disease (CHD): CHD diagnosed by coronary angiography or CTA, or previous history of myocardial infarction, or revascularization (PCI, CABG); (4) Peripheral artery disease (PAD): imaging examination (ultrasound, CTA, MRA or angiography) indicates carotid or lower extremity artery stenosis >50%. Or peripheral vascular revascularization (stent or endarterectomy); (5) Obesity: BMI ≥28
排除标准
- •Intention of catheter ablation of AF in the next 6 months
- •Cardiovascular events (myocardial infarction, etc.) or cardiac surgery in the past 3 months
- •Clinically diagnosed heart failure (objective evidence of elevated natriuretic peptide levels and/or cardiogenic pulmonary/systemic congestion on the basis of structural and/or functional abnormalities) or left ventricular ejection fraction (LVEF) <40%
- •Type 2 diabetic patients with ASCVD or high-risk cardiovascular risk factors (ASCVD includes acute coronary syndrome, stable coronary heart disease, revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic disease. High-risk cardiovascular risk factors include age ≥55 years old, coronary artery/carotid artery/lower extremity artery stenosis >50%, or left ventricular hypertrophy)
- •Type 2 diabetic patients with CKD (eGFR30-60mL/min ·1.73m2)
- •Diabetic patients who are using SGLT2i to control blood glucose
- •Type 1 diabetes
- •Severe renal insufficiency (eGFR < 30mL/ min ·1.73m2), end-stage renal disease or dialysis patients
- •Previous diabetic ketoacidosis
- •Previous allergic reactions to SGLT2i
- •Severe hypoglycemia attacks in the past 12 months
- •Life expectancy less than 1 year
- •Subjects currently participating in other interventional clinical trials
- •Cardiac MRI contraindications (previous implantation of a metal device in the body) or refusal to undergo cardiac MRI
- •The researchers determine that there are factors that will affect the subjects' compliance with the intervention. Such as alcohol abuse, drug abuse, or behavioral disorders
研究组 & 干预措施
Active Comparator: Henagliflozin
Single 5 mg tablet, administered orally once daily for 6 months
干预措施: Henagliflozin 5Mg Tab (Drug)
Placebo Comparator: Placebo
Single 5 mg tablet, administered orally once daily for 6 months
干预措施: placebo (Drug)
结局指标
主要结局
Change in left atrial minimal volume index
时间窗: 6 months
Changes from baseline in left atrial minimal volume index in patients with AF treated with henagliflozin versus placebo using cardiac MRI.
次要结局
- Atrial fibrillation quality of life(6 months)
- Change in left ventricular global longitudinal strain(6 months)
- Change in left ventricular end-diastolic volume index(6 months)
- Change in left ventricular mass(6 months)
- Change in left ventricular end-systolic volume index(6 months)
- Change in left ventricular ejection fraction(6 months)
- Change in extracellular volume(6 months)
- Change in left atrial ejection fraction(6 months)
- Change in left atrial global longitudinal strain(6 months)
- Change in right ventricular mass(6 months)
- Change in right atrial volume index(6 months)
- Change in biomarkers of heart failure(6 months)
- Change in 6min walk test(6 months)
研究者
Chang sheng Ma
Director of Cardiology
Beijing Anzhen Hospital