study to evaluate d-ribose for the treatment of congestive heart failure

Conditions: Congestive Heart Failure

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.

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.

Eligibility criteria:
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 \ 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.

Keywords: chf