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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014