Congestive Heart Failure
Conditions
Keywords
Elevated BNP Levels in CHF patients
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.
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.
Interventions
DRUGCORvalen (D-Ribose)
Sponsors
Valen Labs
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation | — |
Secondary
| Measure | 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. | — |
Countries
United States
Outcome results
None listed