Study To Evaluate D-Ribose For The Treatment of Congestive Heart Failure

July 12, 2016 updated by: RiboCor, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H2W 1T8
        • CHUM Hôtel Dieu
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital / MUHC
  • United States
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Modesto, California, United States, 95350
        • Novo Research, Inc.
      • Sylmar, California, United States, 91342
        • Olive View-UCLA- Medical Center
      • Torrance, California, United States, 90502
        • Harbor-UCLA Medical Center
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Southeast Regional Research Group
      • Macon, Georgia, United States, 31201
        • Mercer University - Mercer Medicine
    • Indiana
      • Muncie, Indiana, United States, 47303
        • Medical Consultants PC
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Louisiana
      • Kenner, Louisiana, United States, 70065
        • MedPharmics
    • Maine
      • Auburn, Maine, United States, 04210
        • Androscoggin Cardiology Associates / dba Maine Research Associates
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Ctr
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • University of Medicine and Dentistry of New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Foundation for Cardiovascular Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Clinical Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Michael Debakey VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:
  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: D-ribose
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.
Drug: D-ribose
D-ribose powder for oral solution and D-ribose for injection.
Other Names:
  • ribose
Placebo Comparator: Placebo
Placebo dosage form designed to mock active.
Other: Placebo
Placebo dosage form designed to mock active.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
LVEF (by 2-D echocardiography): Change from Baseline to Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RiboCor, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Wilson S Colucci, MD, Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC 04C 010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Study terminated due to slow enrollment

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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