NCT07394270尚未招募2 期
Effect of Add-on L-Arginine Therapy on Clinical Outcome of Heart Failure Patients: A Randomized- Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change of Global longitudinal strain value (GLS) of HF patients from the baseline
研究概览
简要总结
Heart failure is considered one of the greatest challenges globally. There are various treatment strategies for heart failure. L-Arginine is an amino acid that was found to have beneficial effect on vasculature. This study aims to study the benefits and side effects of using L-arginine on the patients with ejection fraction <40%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with EF <40%
- •eGFR >30 mL/min/1.73 m2
- •Stable patients
- •Capable and willing to provide written consent
排除标准
- •Patients with implantable cardioverter-defibrillator
- •Pregnant or lactating fmeales
- •Patients with a history of sensitivity to L-Arginine or any of the excipients
- •Acute heart failure patients
- •Patients use L-arginine supplementation.
- •Patients with active herpes disease
研究组 & 干预措施
L-Arginine Arm
Active Comparator
Patients in this arm will be administered 6 gm L-arginine per day
干预措施: L-Arginine Powder (Drug)
Placebo Arm
Placebo Comparator
Patients in this arm will take 6 gm placebo per day
干预措施: Placebo (Drug)
结局指标
主要结局
Change of Global longitudinal strain value (GLS) of HF patients from the baseline
时间窗: 6 weeks
次要结局
- Change of heart failure symptoms as determined by NYHA classification from baseline(6 weeks)
- Change of the functional abilities (ECG) of the patients as determined by the exercise test from baseline(6 weeks)
- Changes in biomarkers of heart failure as determined by the difference in NT-proBNP levels from baseline(6 weeks)
- Change in quality of life between 2 groups as determined by Minnesota Living with Heart Failure questionnaire(6 weeks)
- Safety profile of the L-Arginine as determined by the change in the mean arterial pressure (MAP) between the 2 groups(6 weeks)
- Change in biomarkers of endothelial dysfunction as determined by the difference in levels of endothelin-1(6 weeks)
- Change in biomarkers of endothelial dysfunction as determined by the difference in levels of Asymmetric dimethylarginine (ADMA)(6 weeks)
- Safety profile of the L-Arginine as determined by the change in the heart rate (HR) between the 2 groups(6 weeks)
研究者
Sara Araby
Msc.
German University in Cairo
研究点 (1)
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