The Effect of Ribose on B-Type Natriuretic Peptide (BNP) Levels in Congestive Heart Failure Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Ribose on B-Type Natriuretic Peptide Levels in Congestive Heart Failure Patients

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: CORvalen (D-Ribose)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CORvalen (D-Ribose)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elevated BNP Levels in CHF patients