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:
Information provided by:
Valen Labs
ClinicalTrials.gov Identifier:
NCT00329485
First received: May 23, 2006
Last updated: August 1, 2007
Last verified: August 2007

May 23, 2006
August 1, 2007
June 2006
Not Provided
Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation
Same as current
Complete list of historical versions of study NCT00329485 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effect of Ribose on B-Type Natriuretic Peptide (BNP) Levels in Congestive Heart Failure Patients
The Effect of Ribose on B-Type Natriuretic Peptide Levels in Congestive Heart Failure Patients

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Congestive Heart Failure
Drug: CORvalen (D-Ribose)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
July 2007
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00329485
200602-WA, WIRB Study No. 1076926
No
Not Provided
Valen Labs
Not Provided
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
Valen Labs
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP