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.

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.