Congestive Heart FailurePhase 2NCT01858480
Study To Evaluate D-Ribose For The Treatment of Congestive Heart Failure
A Phase 2 study testing D-ribose in people with Congestive Heart Failure, run by RiboCor, Inc. at 24 sites in 2 countries.
Trial summary
To evaluate the safety and to determine the efficacy of D-ribose for the treatment of congestive heart failure (CHF) in subjects who have been stabilized following hospitalization with acute decompensation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- D-ribose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Jul 2013to Nov 2013
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent and Health Insurance Portability and Accountability Act authorization, as applicable;
- symptomatic heart failure (NYHA Class II, III or IV) ≥ 30 days prior to current acute decompensation episode;
- ≥2 of the following signs of acute decompensation: jugular venous distension, rales, dyspnea, and ≥ 1+ pedal edema;
- admitted to the hospital ≤ 36 hours after initial evaluation;
- discontinued from IV inotropic support ≥ 48 hours prior to Screening;
- initiated Screening when subject has met the following criteria for stabilization:
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- exacerbating factors addressed;
- near optimal volume status;
- transition from IV to oral diuretic completed;
- near optimal pharmacologic therapy achieved or intolerance documented;
- completed Screening procedures and been randomized to treatment ≤ 7 days after hospital admission;
- LVEF ≤ 35% ≤ 12 months prior to Screening.
- if female, ≥ 2 years post-menopausal, surgically sterile, or practicing effective contraception;
- if female, non-lactating, and if of child-bearing potential, has negative pregnancy test result at Screening;
- willing to abstain from ribose-containing products during study.
Who cannot join
- significant medical condition(s) which, in Investigator's judgment, could compromise subject's welfare or confound study results;
- significant hepatic, renal, or hematologic disorder/dysfunction beyond that expected from CHF alone;
- Creatinine Clearance <30.0 mL/min at Screening;
- serum potassium level <3.5 milliequivalent per liter or >5.7 milliequivalent per liter, or a serum sodium level <130 milliequivalent per liter at Screening;
- systolic arterial blood pressure <90 mm Hg at Screening;
- received ultrafiltration during current admission;
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- cardiac surgery ≤ 60 days prior to Screening, except for percutaneous intervention;
- planned revascularization procedures, electrophysiologic device or cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery ≤ 90 days after study enrollment;
- functional mitral valve regurgitation > moderate severity;
- aortic regurgitation of at least moderate severity;
- hemodynamically significant primary cardiac valvular disease;
- myocardial infarction ≤ 30 days prior to Screening;
- Acute Coronary Syndrome ≤ 30 days prior to Screening;
- known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunt;
- sustained ventricular tachycardia or ventricular fibrillation ≤ 30 days prior to Screening, unless automatic implantable cardioverter defibrillator is present;
- atrial fibrillation within the past year;
- CHF related to tachyarrhythmias or bradyarrhythmias;
- CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy;
- angina at rest or with slight exertion and/or unstable angina;
- diagnosed with hypertrophic cardiomyopathy;
- cerebrovascular accident ≤ 6 months prior to Screening;
- cardiogenic shock at any time from initial evaluation to randomization;
- on cardiac mechanical support;
- biventricular pacer placement ≤ 60 days prior to Screening or needed pacemaker placement during the current admission;
- refractory, end-stage heart failure;
- type I or type II diabetes;
- history of pancreatitis;
- current systemic infection;
- urinary tract obstruction;
- morbidly obese (weight > 159 kg [350 lbs] or BMI >42 kg/m2);
- active malignancy at Screening. [Treatment for basal cell or stage 1 squamous cell carcinoma, or cervical carcinoma in situ allowed];
- terminally ill or has moribund condition;
- history of irritable bowel syndrome, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, impaction, or similar gastrointestinal conditions;
- currently taking Kayexalate® (sodium polystyrene sulfonate);
- allergic reaction to Optison™ or Definity® or any of their components.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States20 sites
Androscoggin Cardiology Associates / dba Maine Research Associates
Auburn, Maine, 04210
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Southeast Regional Research Group
Columbus, Georgia, 31904
Genesys Regional Medical Ctr
Grand Blanc, Michigan, 48439
Michael DeBakey VAMC
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
MedPharmics
Kenner, Louisiana, 70065
Long Beach Memorial Medical Center
Long Beach, California, 90806
Mercer University - Mercer Medicine
Macon, Georgia, 31201
Baptist Clinical Research Institute
Memphis, Tennessee, 38120
Novo Research, Inc.
Modesto, California, 95350
Medical Consultants PC
Muncie, Indiana, 47303
Columbia University Medical Center
New York, New York, 10032
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07103
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Stony Brook University Medical Center
Stony Brook, New York, 11794
Olive View-UCLA- Medical Center
Sylmar, California, 91342
Holy Name Medical Center
Teaneck, New Jersey, 07666
Harbor-UCLA Medical Center
Torrance, California, 90502
Canada4 sites
Chum Hotel Dieu
Montreal, Quebec, H2W 1T8
Montreal General Hospital / MUHC
Montreal, Quebec, H3G 1A4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Study To Evaluate D-Ribose For The Treatment Of Congestive Heart Failure
To evaluate the safety and to determine the efficacy of D-ribose for the treatment of congestive heart failure (CHF) in subjects who have been stabilized following hospitalization with acute decompensation.
Read the detailed description
This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center study of D-ribose administered via peripheral intravenous line for 24 hours to stabilized hospitalized patients following standard of care treatment for acute decompensation of CHF, followed by oral dosing of D-ribose three times a daily through the remainder of the inpatient hospital stay and outpatient period of 3 months. Subjects will complete Pretreatment Screening procedures only after the Investigator has established that they have met the pre-specified criteria for stabilization of heart failure, and be randomized to treatment no more than 7 days after admission to the hospital.
- Conditions
- Congestive Heart Failure
- Being tested
- D-ribose, Placebo
- Keywords
- CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-riboseDrug
Also called ribose
D-ribose powder for oral solution and D-ribose for injection.
PlaceboOther
Placebo dosage form designed to mock active.
| Study group | Role | What they receive |
|---|---|---|
| D-ribose | Active comparator | D-ribose administered via peripheral intravenous for 24 hours followed by oral D ribose dosing for 3 months versus placebo in subjects with CHF who have been stabilized following hospitalization for acute decompensation. Receives: Drug: D-ribose |
| Placebo | Placebo comparator | Placebo dosage form designed to mock active. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF), measured by transthoracic 2-D echocardiography with contrast
Efficacy Analyses: The primary efficacy analysis will be performed by comparison of active versus placebo treatment groups. Summary statistics, including means and standard deviations, will be provided. Analysis of covariance will be used to analyze the on-treatment LVEF scores with the pre-treatment LVEF score serving as the covariate.
Measured: LVEF (by 2-D echocardiography): Change from Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Terminated due to slow enrollment
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RiboCor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilson S Colucci, MD, Study chair, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858480
- Sponsor's protocol ID
- RC 04C 010
- Status last verified
- Jul 2016
- First submitted
- 9 May 2013
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study terminated due to slow enrollment
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Study To Evaluate D-Ribose For The Treatment Of Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT01858480
- Acronym / sponsor ID
- RC 04C 010
- Conditions
- Congestive Heart Failure
- Keywords
- CHF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to slow enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RiboCor, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 May 2013 (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.
To evaluate the safety and to determine the efficacy of D-ribose for the treatment of congestive heart failure (CHF) in subjects who have been stabilized following hospitalization with acute decompensation.
Detailed description
This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center study of D-ribose administered via peripheral intravenous line for 24 hours to stabilized hospitalized patients following standard of care treatment for acute decompensation of CHF, followed by oral dosing of D-ribose three times a daily through the remainder of the inpatient hospital stay and outpatient period of 3 months. Subjects will complete Pretreatment Screening procedures only after the Investigator has established that they have met the pre-specified criteria for stabilization of heart failure, and be randomized to treatment no more than 7 days after admission to the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-ribose | Active comparator | Drug: D-riboseD-ribose administered via peripheral intravenous for 24 hours followed by oral D ribose dosing for 3 months versus placebo in subjects with CHF who have been stabilized following hospitalization for acute decompensation. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo dosage form designed to mock active. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- written informed consent and Health Insurance Portability and Accountability Act authorization, as applicable;
- symptomatic heart failure (NYHA Class II, III or IV) ≥ 30 days prior to current acute decompensation episode;
- ≥2 of the following signs of acute decompensation: jugular venous distension, rales, dyspnea, and ≥ 1+ pedal edema;
- admitted to the hospital ≤ 36 hours after initial evaluation;
- discontinued from IV inotropic support ≥ 48 hours prior to Screening;
Key exclusion criteria (35 listed)
- significant medical condition(s) which, in Investigator's judgment, could compromise subject's welfare or confound study results;
- significant hepatic, renal, or hematologic disorder/dysfunction beyond that expected from CHF alone;
- Creatinine Clearance <30.0 mL/min at Screening;
- serum potassium level <3.5 milliequivalent per liter or >5.7 milliequivalent per liter, or a serum sodium level <130 milliequivalent per liter at Screening;
- systolic arterial blood pressure <90 mm Hg at Screening;
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 |
|---|---|---|
| D-riboseAlso: riboseD-ribose powder for oral solution and D-ribose for injection. | Drug | D-ribose |
| PlaceboPlacebo dosage form designed to mock active. | Other | Placebo |
Primary outcome
Left Ventricular Ejection Fraction (LVEF), measured by transthoracic 2-D echocardiography with contrast
Time frame: LVEF (by 2-D echocardiography): Change from Baseline to Month 3
Efficacy Analyses: The primary efficacy analysis will be performed by comparison of active versus placebo treatment groups. Summary statistics, including means and standard deviations, will be provided. Analysis of covariance will be used to analyze the on-treatment LVEF scores with the pre-treatment LVEF score serving as the covariate.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Individual participant dataSharing planned: No. Study terminated due to slow enrollment
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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.
Wilson S Colucci, MD study chair
Boston University
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-ribose in people with Congestive Heart Failure, run by RiboCor, Inc. at 24 sites in 2 countries.
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 15 inclusion and 35 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: withdrawn, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Left Ventricular Ejection Fraction (LVEF), measured by transthoracic 2-D echocardiography with contrast (time frame: LVEF (by 2-D echocardiography): Change from Baseline to Month 3). 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 14 Jul 2016.