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

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.

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.