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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT01858480

Run by

RiboCor, Inc.

People needed

0

Starts

2013-07-01

Expected to finish

2013-11-01

Last updated by the study team

2016-07-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Long Beach Memorial Medical Center — Long Beach, California, United States
• Novo Research, Inc. — Modesto, California, United States
• Olive View-UCLA- Medical Center — Sylmar, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Southeast Regional Research Group — Columbus, Georgia, United States
• Mercer University - Mercer Medicine — Macon, Georgia, United States
• Medical Consultants PC — Muncie, Indiana, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• MedPharmics — Kenner, Louisiana, United States
• Androscoggin Cardiology Associates / dba Maine Research Associates — Auburn, Maine, United States
• University of Maryland, Baltimore — Baltimore, Maryland, United States
• Genesys Regional Medical Ctr — Grand Blanc, Michigan, United States
• University of Medicine and Dentistry of New Jersey — Newark, New Jersey, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Oklahoma Foundation for Cardiovascular Research — Oklahoma City, Oklahoma, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Baptist Clinical Research Institute — Memphis, Tennessee, United States
• Michael DeBakey VAMC — Houston, Texas, United States
• St. Michael's Hospital — Toronto, Ontario, Canada
• Chum Hotel Dieu — Montreal, Quebec, Canada
• Montreal General Hospital / MUHC — Montreal, Quebec, Canada
• Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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