The Effect of Ribose on B-Type Natriuretic Peptide (BNP) Levels in Congestive Heart Failure Patients
This study has been terminated.
(Poor recruitment and through put)
Sponsor:
Valen Labs
Information provided by:
Valen Labs
ClinicalTrials.gov Identifier:
NCT00329485
First received: May 23, 2006
Last updated: August 1, 2007
Last verified: August 2007
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Purpose
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 | Intervention |
|---|---|
|
Congestive Heart Failure |
Drug: CORvalen (D-Ribose) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | The Effect of Ribose on B-Type Natriuretic Peptide Levels in Congestive Heart Failure Patients |
Resource links provided by NLM:
Further study details as provided by Valen Labs:
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.
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2006 |
| Study Completion Date: | July 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329485
Locations
| United States, Ohio | |
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00329485 History of Changes |
| Other Study ID Numbers: | 200602-WA, WIRB Study No. 1076926 |
| Study First Received: | May 23, 2006 |
| Last Updated: | August 1, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Valen Labs:
|
Elevated BNP Levels in CHF patients |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Natriuretic Peptide, Brain Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013