The Impact of Pomegranate (Punica Granatum) Polyphenol Extract on Oxidative Stress, Ventricular Remodeling and Endothelial Function in Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Thiobarbituric Reactive Substances (TBARS)
研究概览
简要总结
This blinded, controlled study will examine the impact of pomegranate polyphenol extract (POMx, from Pom Wonderful, LLC), 1000mg on cardiomyopathy in subjects with chronic renal insufficiency.
详细描述
Heart failure (HF) is a disease of great prevalence in the U.S. with an associated high morbidity and mortality. In individuals with concomitant chronic renal insufficiency (CRI), outcomes are even worse due to pharmaceutical under treatment and higher baseline levels of oxidative stress. Reactive oxygen species (ROS) are generated during mechanoenergetic uncoupling and can cause myocardial protein, lipid, and DNA damage, leading to the development of HF. One means of preventing the progression of HF may be through ROS reduction or an improvement in systemic or local oxidative stress handling. In this randomized, single blind placebo-controlled pilot study, we hypothesize that 12 weeks of treatment with oral pomegranate extract (POMx) will lead to a reduction in oxidative stress (as assessed by measuring thiobarbituric acid-reactive substances, F8-isoprostanes, and glutathione) in subjects (n=30) with cardiomyopathy (LVEF ≤40%) and CRI (GFR <60 ml/hr). Secondary aims include assessing the impact of POMx on myocardial remodeling and endothelial dysfunction by measuring serum collagen levels and asymmetric dimethylarginine, respectively. Findings from this study will serve as pilot data for a larger randomized trial of longer term POMx therapy in subjects with cardiomyopathy.
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
- Single (Participant)
盲法说明
The participant will either receive POMx or matching placebo (sugar pill)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (≥21 years of age) with cardiomyopathy (ejection fraction ≤40%) of at least 1 year duration and CRI (GFR <60 cc/hr for at least 3 months) will be eligible for enrollment.
- •Subjects must have New York Heart Association (NYHA) functional class I-III symptoms and be on stable doses of HF evidence-based therapies (β-blocker, ACE inhibitor or ARBs, aldosterone inhibitor [if appropriate]) for at least 3 months or have a documented contraindication or intolerance to such therapy
排除标准
- •Subjects admitted to a hospital for acute myocardial infarction (defined as positive troponins) or HF exacerbation within the last 6 months will not be eligible for enrollment.
- •Subjects on warfarin or rosuvastatin will also be excluded.
- •Other exclusion criteria are as follows:
- •HF that is deemed to be congenital or infiltrative in etiology
- •the presence of a life-threatening illness with a projected survival ≤6 months; ongoing infection
- •pregnancy
- •inability to follow-up
- •end-stage renal disease requiring dialysis
- •renal transplant listing
- •recent (within last 6 months) POMx use or intake >8 ounces daily of pomegranate juice
- •known hypersensitivity to any fruit in the Punicaceae family
- •connective tissue or collagen vascular disease
研究组 & 干预措施
POMx
15 subjects will received 1000 mg of oral POMx for 12 weeks.
干预措施: POMx, pomegranate polyphenol extract (Drug)
Control- sugar Pill
15 subjects will receive a matching sugar pill for 12 weeks.
干预措施: Sugar Pill (Drug)
结局指标
主要结局
Thiobarbituric Reactive Substances (TBARS)
时间窗: baseline and after 12 weeks
This is a serum marker of oxidative stress.
次要结局
- Asymmetric Dimethylarginine (ADMA)(baseline and 12 weeks)
- Procollagen Types I (PINP) and III (PIIINP)(baseline and 12 weeks)
- F-8 Isoprostanes(Baseline and 12 weeks)
研究者
Jennifer Cowger , MD, MS
Assistant Professor, study PI
University of Michigan