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TerminatedNCT00329485Updated Aug 2, 2007

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

An interventional study of CORvalen (D-Ribose) in Congestive Heart Failure, sponsored by Valen Labs. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-08-02.

Sponsored by Valen Labs · Not applicable and Interventional

Why this study was terminated
Poor recruitment and through put
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Congestive Heart Failure

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Keywords

  • Elevated BNP Levels in CHF patients
03

In context

Heart Failure

5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 120 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

This is the only study on the registry with Valen Labs as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants

Interventions

  • DrugCORvalen (D-Ribose)
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  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.

07

Study locations

1 site
  • See list of Study Principal Investigators
    Columbus, Ohio, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00329485
Lead sponsor
Valen Labs
First posted
May 24, 2006
Start date
Jun 2006
Completion
Jul 2007
Last update
Aug 2, 2007

Study contacts

Garrie Haas, MD
principal investigator · Ohio State University
Mark Munger, PharmD
principal investigator · University of Utah
Reynolds Delgado, MD
principal investigator · Texas Heart Institute
Daniel Pauly, MD, PhD
principal investigator · University of Florida
Kris Vijay, MD
principal investigator · Scottsdale Cardiovascular Research Institute
Masoor Kamalesh, MD
principal investigator · Roudebush VA Medical Center
Robert J Weiss, MD
principal investigator · Maine Research Associates

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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