Study Stopped
Poor recruitment and through put
The Effect of Ribose on B-Type Natriuretic Peptide (BNP) Levels in Congestive Heart Failure Patients
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedAugust 2, 2007
August 1, 2007
May 23, 2006
August 1, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation
Secondary Outcomes (2)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Valen Labslead
Study Sites (1)
See list of Study Principal Investigators
Columbus, Ohio, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 23, 2006
First Posted
May 24, 2006
Study Start
June 1, 2006
Study Completion
July 1, 2007
Last Updated
August 2, 2007
Record last verified: 2007-08