Efficacy and Safety of Coenzyme I for Injection on Vascular Aging.

Официальное название

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）

Обзор

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.

Вмешательства

• Препарат Coenzyme I for Injection
  Subjects receive 7 consecutive days of intravenous infusion of Coenzyme I for injection.
• Препарат NaCl (placebo)
  Subjects receive 7 consecutive days of intravenous infusion of NaCl(0.9%).

Первичные конечные точки

• The change in flow-mediated vasodilation(FMD) [Срок оценки: Day 8/28]

Вторичные конечные точки (6)

• Changes in cf-PWV. [Срок оценки: day 8/28]
• Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR) [Срок оценки: day 8/28]
• Changes in the level of NAD+ [Срок оценки: day 8/28]
• Changes in the metabolomics. [Срок оценки: day 8/28]
• Changes in office blood pressure and 24-hour ambulatory blood pressure [Срок оценки: day 8/28]
• The change in the urine albumin-to-creatinine ratio [Срок оценки: day 8/28]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Tenth People's Hospital — Шанхай

Идентификаторы

NCT: NCT07328100 · NAD-VA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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