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

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.