Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To assess the effect of liposomal L-Arg and Vit C
研究概览
简要总结
Pilot study to assess the effect of L-Arg and Vit C liposomal supplementation on mitochondrial function in patients with heart failure, through analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC).
详细描述
Pilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trial.
The primary objective of this study is to assess the effect of liposomal L-Arg and Vit C supplementation on mitochondrial function in patients with heart failure, by analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC). Mitochondrial respiratory function of PBMC (in extensive lymphocytes and monocytes) is readily available. These cells are involved in many inflammatory diseases, including those driven by episodes of ischemia-reperfusion, which play a key role in cardiovascular alterations. In particular, the recruitment of T cells and myocardial infiltration are well described during ischemic and non-sischemic heart failure, so the mitochondrial function of PBMC could play a significant role in this immune disorderrelated during heart failure.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosis of heart failure with preserved EF 45%.
排除标准
- •Age <18 years
- •Left ventricular ejection fraction <45%
- •Valvular heart disease
- •Previous myocardial infarction or coronary heart disease
- •Hypertension
- •Diabetes mellitus
- •Intolerance to L-arginine and liposomal vitamin C
- •Pregnancy
- •Lactation.
研究组 & 干预措施
Treatment group
Once the diagnosis of heart failure is established, patients will be randomized into a double-blind treatment to receive with a 1:1 ratio an oral supplement of 1.66 g L-arginine and 500 mg of liposomal vitamin C once a day (Bioarginine. C , Pharmaceutical Damor) for 3 months (treatment group)
干预措施: L-arginine and liposomal vitamin C (Drug)
结局指标
主要结局
To assess the effect of liposomal L-Arg and Vit C
时间窗: 3 months
The primary objective of this study is to assess the effect of liposomal L-Arg and Vit C supplementation on mitochondrial function in patients with heart failure, by analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC).
次要结局
未报告次要终点
研究者
Stefano Carugo
Director of the Department of Cardio-Thoracic-Vascular Diseases
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico