Congestive Heart FailureNCT00329485
The Effect of Ribose on B-Type Natriuretic Peptide (BNP) Levels in Congestive Heart Failure Patients
A study testing CORvalen (D-Ribose) in people with Congestive Heart Failure, run by Valen Labs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- CORvalen (D-Ribose)
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- History of non-compliance
- Pregnancy
- Current enrollment in any other clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
See list of Study Principal Investigators
Columbus, Ohio
About this study
Official title: The Effect of Ribose on B-Type Natriuretic Peptide Levels in Congestive Heart Failure Patients
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.
- Conditions
- Congestive Heart Failure
- Being tested
- CORvalen (D-Ribose)
- Keywords
- Elevated BNP Levels in CHF patients
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORvalen (D-Ribose)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startJun 2006
- Study completionJul 2007
Why it stopped: Poor recruitment and through put
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Valen Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Garrie Haas, MD, Principal investigator, Ohio State UniversityMark Munger, PharmD, Principal investigator, University of UtahReynolds Delgado, MD, Principal investigator, Texas Heart InstituteDaniel Pauly, MD, PhD, Principal investigator, University of FloridaKris Vijay, MD, Principal investigator, Scottsdale Cardiovascular Research InstituteMasoor Kamalesh, MD, Principal investigator, Roudebush VA Medical CenterRobert J Weiss, MD, Principal investigator, Maine Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329485
- Sponsor's protocol ID
- 200602-WA
- Other IDs
- WIRB Study No. 1076926
- Status last verified
- Aug 2007
- First submitted
- 23 May 2006
- Last updated
- 2 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ribose on B-Type Natriuretic Peptide Levels in Congestive Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00329485
- Acronym / sponsor ID
- 200602-WA
- Conditions
- Congestive Heart Failure
- Keywords
- Elevated BNP Levels in CHF patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment and through put
- Enrolment
- 120 participants
- Lead sponsor
- Valen LabsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 24 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CORvalen (D-Ribose) | Drug | – |
Primary outcome
Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation
2 secondary outcomes
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.
Results and safety
The study was stopped early (reason given: Poor recruitment and through put). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2007.
Related trials for Congestive Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garrie Haas, MD principal investigator
Ohio State University
Mark Munger, PharmD principal investigator
University of Utah
Reynolds Delgado, MD principal investigator
Texas Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CORvalen (D-Ribose) in people with Congestive Heart Failure, run by Valen Labs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment and through put). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate a significant reduction in serial BNP values over 3 months while on ribose supplementation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2007.