CTRI/2025/07/091956尚未招募不适用
Efficacy of neuraminidase inhibition in hypertension with left ventricular hypertrophy
Postgraduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年8月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in LVGLS
研究概览
简要总结
· This is a double blinded, randomised, parallel group, placebo controlled clinical study to be conducted in the Department of Cardiology and Pharmacology, PGIMER, Chandigarh. The purpose is to assess the efficacy and safety of neuraminidase inhibitor in hypertension with left ventricular hypertrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •18year of age or older, regardless of gender.
- •Diagnosed with essential hypertension for at least 1 year Have been on stable antihypertensive medication for a minimum of 3 months before screening.
- •Have a diagnosis of LVH confirmed by echocardiography, with LVMI of more than or equal to 115g/m² for males and more than equal to 95g/m² for females.
- •Provide written informed consent.
排除标准
- •Women who are pregnant and lactating Patients with valvular heart diseases (MR, AR).
- •Patient with inadequate echocardiographic windows.
- •Suboptimal automated speckle tracking across multiple myocardial segment.
- •Any LV regional wall motion abnormalities.
- •Atrial fibrillation, frequent ectopic, left bundle branch block, paced rhythm, or atrioventricular block.
- •Known secondary causes of HTN.
- •Known chronic kidney disease, retinopathy, or cerebrovascular diseases.
- •Known case of congenital heart disease.
- •Any history of previous cardiac surgery.
结局指标
主要结局
Change in LVGLS
时间窗: At 0, 12, and 24 weeks
次要结局
- incidence of adverse events and serious adverse events(12 and 24 weeks)
- Changes in left ventricular mass index.(12, and 24 weeks)
- Changes in fractional shortening(12 and 24 weeks)
- Left ventricle posterior wall diameter in systole (LVPWs)(12 and 24 weeks)
- Left ventricle posterior wall diameter in diastole (LVPWd)(12 and 24 weeks)
- Interventricular septal thickness systole (IVSTs)(12 and 24 weeks)
- Interventricular septal thickness diastole (IVSTd)(12 and 24 weeks)
研究者
Dr Kamal Singh Ladwal
PGIMER chandigarh
研究点 (1)
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