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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00329485
• Other study ID #: 200602-WA
• Secondary ID: WIRB Study No. 1
• Status: Terminated
• Phase: N/A
• First received: May 23, 2006
• Last updated: August 1, 2007
• Start date: June 2006
• Est. completion date: July 2007

Study information

• Verified date: August 2007
• Source: Valen Labs
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• CORvalen (D-Ribose)

Locations

Country	Name	City	State
United States	See list of Study Principal Investigators	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Valen Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation
Secondary	Demonstrate significant improvement in serial six minute hall walks while on ribose supplementation
Secondary	Demonstrate significant improvement in quality of life as measured by the Minnesota, Living with Heart Failure Questionnaire.