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

August 1, 2007 updated by: Valen Labs

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States
        • See list of Study Principal Investigators

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

May 23, 2006

First Submitted That Met QC Criteria

May 23, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Estimate)

August 2, 2007

Last Update Submitted That Met QC Criteria

August 1, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200602-WA
  • WIRB Study No. 1076926

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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