Clinical trial NCT00329485: The Effect of Ribose on B-Type Natriuretic Peptide (BNP) Levels in Congestive Heart Failure Patients
Official title: The Effect of Ribose on B-Type Natriuretic Peptide Levels in Congestive Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Elevated BNP Levels in CHF patients
Lead sponsor: Valen Labs
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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.

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 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

Primary outcomes:
measure: Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation
Secondary outcomes:
measure: Demonstrate significant improvement in serial six minute hall walks while on ribose supplementation
measure: Demonstrate significant improvement in quality of life as measured by the Minnesota, Living with Heart Failure Questionnaire.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: See list of Study Principal Investigators
state: Ohio
Study officials:
affiliation: Ohio State University
name: Garrie Haas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Mark Munger, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Heart Institute
name: Reynolds Delgado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Daniel Pauly, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scottsdale Cardiovascular Research Institute
name: Kris Vijay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Roudebush VA Medical Center
name: Masoor Kamalesh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maine Research Associates
name: Robert J Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: