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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 )

Sponsored by: Valen Labs
Information provided by: Valen Labs
ClinicalTrials.gov Identifier: NCT00329485
  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)

MedlinePlus related topics:   Heart Failure   

ChemIDplus related topics:   Nesiritide    Ribose   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   The Effect of Ribose on B-Type Natriuretic Peptide Levels in Congestive Heart Failure Patients

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

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.

  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


Study ID Numbers:   200602-WA, WIRB Study No. 1076926
First Received:   May 23, 2006
Last Updated:   August 1, 2007
ClinicalTrials.gov Identifier:   NCT00329485
Health Authority:   United States: Institutional Review Board

Keywords provided by Valen Labs:
Elevated BNP Levels in CHF patients  

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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