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

Sponsor
RiboCor, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01858480
Collaborator
(none)
0
Enrollment
24
Locations
2
Arms
4
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized, Double-Blind, Placebo-Controlled Study To Evaluate D-Ribose For The Treatment Of Congestive Heart Failure
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

    Outcome Measures

    Primary Outcome Measures

    1. Left Ventricular Ejection Fraction (LVEF), measured by transthoracic 2-D echocardiography with contrast [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Long Beach Memorial Medical Center Long Beach California United States 90806
    2 Novo Research, Inc. Modesto California United States 95350
    3 Olive View-UCLA- Medical Center Sylmar California United States 91342
    4 Harbor-UCLA Medical Center Torrance California United States 90502
    5 Southeast Regional Research Group Columbus Georgia United States 31904
    6 Mercer University - Mercer Medicine Macon Georgia United States 31201
    7 Medical Consultants PC Muncie Indiana United States 47303
    8 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
    9 MedPharmics Kenner Louisiana United States 70065
    10 Androscoggin Cardiology Associates / dba Maine Research Associates Auburn Maine United States 04210
    11 University of Maryland, Baltimore Baltimore Maryland United States 21201
    12 Genesys Regional Medical Ctr Grand Blanc Michigan United States 48439
    13 University of Medicine and Dentistry of New Jersey Newark New Jersey United States 07103
    14 Holy Name Medical Center Teaneck New Jersey United States 07666
    15 Columbia University Medical Center New York New York United States 10032
    16 Stony Brook University Medical Center Stony Brook New York United States 11794
    17 Oklahoma Foundation for Cardiovascular Research Oklahoma City Oklahoma United States 73120
    18 Drexel University College of Medicine Philadelphia Pennsylvania United States 19102
    19 Baptist Clinical Research Institute Memphis Tennessee United States 38120
    20 Michael DeBakey VAMC Houston Texas United States 77030
    21 St. Michael's Hospital Toronto Ontario Canada M5B 1W8
    22 Chum Hotel Dieu Montreal Quebec Canada H2W 1T8
    23 Montreal General Hospital / MUHC Montreal Quebec Canada H3G 1A4
    24 Jewish General Hospital Montreal Quebec Canada H3T 1E2

    Sponsors and Collaborators

    • RiboCor, Inc.

    Investigators

    • Study Chair: Wilson S Colucci, MD, Boston University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RiboCor, Inc.
    ClinicalTrials.gov Identifier:
    NCT01858480
    Other Study ID Numbers:
    • RC 04C 010
    First Posted:
    May 21, 2013
    Last Update Posted:
    Jul 14, 2016
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by RiboCor, Inc.
    CHF
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jul 14, 2016