The Effect of Ribose on B-Type Natriuretic Peptide Levels in Congestive Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation
研究概览
简要总结
The purpose of this research study is to test the effectiveness of CORvalen, a medical food, to increase cellular energy sufficiently to change or modify BNP levels in congestive heart failure patients.
详细描述
B-type natriuretic peptide (BNP), is a blood test commonly used to track the progress of congestive heart failure. CORvalen, a medical food, contains D-Ribose (ribose), a natural substance that has been shown to improve the amount of energy compounds at the cellular level. Congestive heart failure has been associated with a reduced level of high-energy compounds. One researcher has called them an "energy starvation" in congestive heart failure. This study will try to assess if increasing the amount of these energy compounds is sufficient to improve BNP levels. Approximately 120 symptomatic congestive heart failure patients will participate in this 3 month study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic adults, M/F, between 18 and 80 years of age
- •BNP levels equal to or greater than 300 pg/ml.
- •Primary or secondary diagnosis of congestive heart failure at the time of admission (any NYHA Class)
- •Diagnosis of congestive heart failure for at least 3 months
- •Able to perform 6 minute hall walk
- •No therapeutic pharmaceutical class changes for at least 1 month
- •Provide informed consent
- •A 30-day washout period must be achieved for any patient involved in a previous clinical study.
- •Insulin dependent diabetes (Type I)
- •History of obstructive valvular disease
- •History of pulmonary hypertension within the last 3 months
- •History of hypertrophic or alcoholic cardiomyopathy
- •History of restrictive cardiomyopathy
- •History of reversible cardiomyopathy
- •History of non-compliance
- •Pregnancy
- •Current enrollment in any other clinical study
排除标准
- 未提供
结局指标
主要结局
Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation
次要结局
- Demonstrate significant improvement in serial six minute hall walks while on ribose supplementation
- Demonstrate significant improvement in quality of life as measured by the Minnesota, Living with Heart Failure Questionnaire.