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

NCT ID: NCT00329485

Last Updated: 2007-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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CORvalen (D-Ribose)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valen Labs

INDUSTRY

Sponsor Role lead

Principal Investigators

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Garrie Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Mark Munger, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Reynolds Delgado, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Heart Institute

Daniel Pauly, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Kris Vijay, MD

Role: PRINCIPAL_INVESTIGATOR

Scottsdale Cardiovascular Research Institute

Masoor Kamalesh, MD

Role: PRINCIPAL_INVESTIGATOR

Roudebush VA Medical Center

Robert J Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Maine Research Associates

Locations

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See list of Study Principal Investigators

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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WIRB Study No. 1076926

Identifier Type: -

Identifier Source: secondary_id

200602-WA

Identifier Type: -

Identifier Source: org_study_id