Status:
WITHDRAWN
Study To Evaluate D-Ribose For The Treatment of Congestive Heart Failure
Lead Sponsor:
RiboCor, Inc.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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 decompens...
Detailed Description
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 followin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01858480
Start Date
July 1 2013
End Date
November 1 2013
Last Update
July 14 2016
Active Locations (24)
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1
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
2
Novo Research, Inc.
Modesto, California, United States, 95350
3
Olive View-UCLA- Medical Center
Sylmar, California, United States, 91342
4
Harbor-UCLA Medical Center
Torrance, California, United States, 90502