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

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• Status: Withdrawn
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Drug: D-ribose; Other: Placebo

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: Interventional
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	LVEF (by 2-D echocardiography): Change from Baseline to Month 3

Collaborators and Investigators

• Sponsor: RiboCor, Inc.
• Investigators: Study Chair: Wilson S Colucci, MD, Boston University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: May 9, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Estimate): July 14, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: CHF
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID 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