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

• Status: Withdrawn
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RiboCor, Inc.

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 <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.