Examining the Effects of Mitochondrial Oxidative Stress in DCM
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Vanguard phase - change in myocardial PCr:ATP
研究概览
简要总结
Double blind, randomised, placebo-controlled trial of MitoQ (mitoquinol mesylate) in 106 patients with dilated cardiomyopathy, examining the effect of reducing mitochondrial oxidative stress on myocardial energetics and myocardial function using 31-phosphorus magnetic resonance spectroscopy and cardiovascular magnetic resonance.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MitoQ
Mitoquinol mesylate 40mg daily
干预措施: MitoQ Compound (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Vanguard phase - change in myocardial PCr:ATP
时间窗: 3 months
The first 34 patients will enter a 3 months Vanguard phase. Change in myocardial PCr:ATP between baseline and follow-up will be measured using 31P magnetic resonance spectroscopy
Vanguard phase - change in circulating markers of oxidative stress
时间窗: 3 months
The first 34 patients will enter a 3 months Vanguard phase. Change in circulating oxLDL and F2isoprostanes will be measured in plasma samples
Primary outcome - change in LVESVi
时间窗: 12 months
Change in LVESVi (ml/m2) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
次要结局
- Vanguard phase - change in skeletal muscle PCr recovery(3 months)
- Follow-on phase - change in LVEDVi(12 months)
- Follow-on phase - change in renal function(12 months)
- Follow-on phase - change in GLS(12 months)
- Follow-on phase - change in LVEF(12 months)
- Follow-on phase - change in symptom burden(12 months)
- Follow-on phase - change in exercise capacity(12 months)
- Follow-on phase - change in NT-pro-BNP(12 months)