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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329485
Recruitment Status : Terminated (Poor recruitment and through put)
First Posted : May 24, 2006
Last Update Posted : August 2, 2007
Information provided by:
Valen Labs

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
Congestive Heart Failure Drug: CORvalen (D-Ribose) Not Applicable

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 Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Effect of Ribose on B-Type Natriuretic Peptide Levels in Congestive Heart Failure Patients
Study Start Date : June 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Primary Outcome Measures :
  1. Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation

Secondary Outcome Measures :
  1. Demonstrate significant improvement in serial six minute hall walks while on ribose supplementation
  2. Demonstrate significant improvement in quality of life as measured by the Minnesota, Living with Heart Failure Questionnaire.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00329485

United States, Ohio
See list of Study Principal Investigators
Columbus, Ohio, United States
Sponsors and Collaborators
Valen Labs
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 Identifier: NCT00329485     History of Changes
Other Study ID Numbers: 200602-WA
WIRB Study No. 1076926
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: August 2, 2007
Last Verified: August 2007

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