Effect of Folic Acid Supplementation in Patient's Calcific Aortic Valve Disease With Mild Aortic Valve Stenosis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- overall survival
研究概览
简要总结
This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of folic acid compared to placebo in patients with calcific aortic valve disease with mild aortic valve stenosis.
详细描述
Folic acid is involved in important physiological activities in the body such as DNA synthesis, cell division and growth and development. Recent studies have shown that folic acid may also have a positive effect on cardiovascular system health. Aortic valve calcification is a cardiovascular disease whose incidence increases progressively with age. Early studies suggest that folic acid may slow the progression of aortic valve calcification by inhibiting cell calcification and promoting calcium deposition. Participants were randomized into two groups: one group was given oral folic acid treatment and the other group was given placebo control. Patients in both groups were observed for aortic valve calcification during the follow-up period, and changes in aortic valve thickness, degree of calcification, and flow were recorded by cardiac ultrasonography, while the incidence of cardiovascular events and adverse effects were assessed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult ≥ 35 years of age at the time of recruiting.
- •Subject has calcific aortic valve disease with mild to moderate aortic valve stenosis as defined by Doppler echocardiography results: Aortic Valve mean pressure gradient between 10-30 mmHg and Aortic Valve Area ≥ 1.2 and ≤ 2.0 cm2 on transthoracic echocardiography within 2 weeks prior to randomization and Cardiac Compute Tomography (CT) test results: aortic valve calcium score (Agatston score) ≥ 200 AU at baseline cardiac CT within 1 month prior to randomization
- •Subject provides written informed consent prior to initiation of any study procedures.
- •Subject understands and agrees to comply with planned study procedures.
排除标准
- •Subject has concomitant moderate or severe mitral or tricuspid valve disease.
- •Subject has left ventricular ejection fraction < 50%.
- •Subject previous history of aortic valve surgery, pancreatitis, malignant tumor, drug or alcohol abuse.
- •Subjects whose alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 times the upper limit of normal range.
- •Subjects who cannot undergo Cardiac CT.
- •Pregnant or lactating women.
- •Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment.
研究组 & 干预措施
Drug group 1
Dietary Supplement: Folic acid 2.5 mg/day
干预措施: Folic Acid Oral Tablet (Drug)
Control group 2
Dietary Supplement: Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
overall survival
时间窗: 3 years
overall survival (OS)
Aortic valve calcification
时间窗: 104 weeks
Aortic valve calcification as measured by change from baseline in Agatston arbitrary unit (AU) using cardiac computed tomography (CT) at 104 weeks
次要结局
- Time-to-major adverse cardiovascular events(104 weeks)
- Aortic valve calcification(at week 52)
- Change in aortic valve stenosis severity(at week 104)