The Effect of Ribose on B-Type Natriuretic Peptide (BNP) Levels in Congestive Heart Failure Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation []
Secondary Outcome Measures
- 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. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Symptomatic adults, M/F, between 18 and 80 years of age
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BNP levels equal to or greater than 300 pg/ml.
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Primary or secondary diagnosis of congestive heart failure at the time of admission (any NYHA Class)
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Diagnosis of congestive heart failure for at least 3 months
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Able to perform 6 minute hall walk
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No therapeutic pharmaceutical class changes for at least 1 month
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Provide informed consent
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A 30-day washout period must be achieved for any patient involved in a previous clinical study.
Exclusion
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Insulin dependent diabetes (Type I)
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History of obstructive valvular disease
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History of pulmonary hypertension within the last 3 months
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History of hypertrophic or alcoholic cardiomyopathy
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History of restrictive cardiomyopathy
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History of reversible cardiomyopathy
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History of non-compliance
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Pregnancy
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Current enrollment in any other clinical study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | See list of Study Principal Investigators | Columbus | Ohio | United States |
Sponsors and Collaborators
- Valen Labs
Investigators
- Principal Investigator: Garrie Haas, MD, Ohio State University
- Principal Investigator: Mark Munger, PharmD, University of Utah
- Principal Investigator: Reynolds Delgado, MD, Texas Heart Institute
- Principal Investigator: Daniel Pauly, MD, PhD, University of Florida
- Principal Investigator: Kris Vijay, MD, Scottsdale Cardiovascular Research Institute
- Principal Investigator: Masoor Kamalesh, MD, Roudebush VA Medical Center
- Principal Investigator: Robert J Weiss, MD, Maine Research Associates
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 200602-WA
- WIRB Study No. 1076926