A Randomized, Double-blind, Parallel Controlled Clinical Trial to Evaluate the Efficacy of Coenzyme I for Injection in the Treatment of Vascular Aging（Pilot Stydy）
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change in flow-mediated vasodilation(FMD)
研究概览
简要总结
Emerging evidence identifies vascular aging independently predicting cardiovascular events, yet effective clinical interventions remain lacking. Nicotinamide adenine dinucleotide (NAD+) is an essential cofactor whose levels decline with age, and preclinical studies suggest that boosting NAD+ can improve vascular function and structure. Preliminary clinical studies in healthy older adults indicate that supplementation with NAD+ precursors, such as nicotinamide riboside(NR) or nicotinamide mononucleotide (NMN), can reduce arterial stiffness as measured by pulse wave velocity (PWV). However, whether NAD+ supplementation can improve vascular endothelial function and exert anti-stiffening effects in patients who have already developed measurable arterial stiffness remains unknown. Based on this evidence, the investigator hypothesize that the Coenzyme I for Injection will reverse vascular aging in older adults with established arterial stiffening.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 40-70 years;
- •cf-PWV was abnormally elevated and above the upper limit of its age-and blood-pressure matched reference range;
- •Systolic Blood Pressure < 160 mmHg and ≥ 140 mmHg or Diastolic BP < 100 mmHg ≥ 90mmHg;
- •Signed informed consent.
排除标准
- •Consumption of foods or medications containing high levels of NAD+, NR, NAM, NMN, or niacin-related components (including Vitamin B3 and natural health products) within 3 months prior to screening；
- •History of major cardiovascular or cerebrovascular events, including myocardial infarction, angina, stroke, or hospitalization for arterial revascularization；
- •Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg；
- •Diagnosis of malignant tumor；
- •Known allergy or history of severe adverse reactions to Coenzyme I injection or any of its components；
- •History of severe allergies or infusion reactions；
- •Women who are pregnant, breastfeeding, or planning pregnancy；
- •Severe hepatic or renal dysfunction: ALT or AST > 5 times the upper limit of normal; glomerular filtration rate ≤ 30 mL/min/1.73 m²；
- •Concurrent participation in another clinical trial without completion of the follow-up period；
- •Other conditions deemed by the investigator as unsuitable for inclusion, such as psychiatric or psychological disorders.
研究组 & 干预措施
Intervention Group
干预措施: Coenzyme I for Injection (Drug)
Control Group
干预措施: NaCl (placebo) (Drug)
结局指标
主要结局
The change in flow-mediated vasodilation(FMD)
时间窗: Day 8/28
Changes in FMD from baseline to day 8/28.
次要结局
- Changes in cf-PWV.(day 8/28)
- Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR)(day 8/28)
- Changes in the level of NAD+(day 8/28)
- Changes in the metabolomics.(day 8/28)
- Changes in office blood pressure and 24-hour ambulatory blood pressure(day 8/28)
- The change in the urine albumin-to-creatinine ratio(day 8/28)
研究者
Ya-Wei Xu
Senior doctor, Professor
Shanghai 10th People's Hospital