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

NCT ID: NCT01858480

Last Updated: 2016-07-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-11-30

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 decompensation.

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 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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

D-ribose

D-ribose administered via peripheral intravenous for 24 hours followed by oral D ribose dosing for 3 months versus placebo in subjects with CHF who have been stabilized following hospitalization for acute decompensation.

Group Type: ACTIVE_COMPARATOR

D-ribose

Intervention Type: DRUG

D-ribose powder for oral solution and D-ribose for injection.

Placebo

Placebo dosage form designed to mock active.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo dosage form designed to mock active.

Interventions

D-ribose

D-ribose powder for oral solution and D-ribose for injection.

Intervention Type: DRUG

Placebo

Placebo dosage form designed to mock active.

Intervention Type: OTHER

Other Intervention Names

ribose

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 <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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RiboCor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilson S Colucci, MD

Role: STUDY_CHAIR

Boston University

Locations

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

Countries

United States; Canada

Other Identifiers

RC 04C 010

Identifier Type: -

Identifier Source: org_study_id