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

NCT01858480 | Withdrawn Phase 2

• 1 other identifier: RC 04C 010
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 24

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.

Conditions

Congestive Heart Failure

Keywords

CHF

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Ejection Fraction (LVEF), measured by transthoracic 2-D echocardiography with contrast

  Efficacy Analyses: The primary efficacy analysis will be performed by comparison of active versus placebo treatment groups. Summary statistics, including means and standard deviations, will be provided. Analysis of covariance will be used to analyze the on-treatment LVEF scores with the pre-treatment LVEF score serving as the covariate.

  LVEF (by 2-D echocardiography): Change from Baseline to Month 3

Study Arms (2)

D-ribose

ACTIVE COMPARATOR

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.

Drug: D-ribose

Placebo

PLACEBO COMPARATOR

Placebo dosage form designed to mock active.

Other: Placebo

Interventions

D-ribose DRUG

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

Also known as: ribose

D-ribose

Placebo OTHER

Placebo dosage form designed to mock active.

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• RiboCor, Inc.: lead

Study Sites (24)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Novo Research, Inc.

Modesto, California, 95350, United States

Location

Olive View-UCLA- Medical Center

Sylmar, California, 91342, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Southeast Regional Research Group

Columbus, Georgia, 31904, United States

Location

Mercer University - Mercer Medicine

Macon, Georgia, 31201, United States

Location

Medical Consultants PC

Muncie, Indiana, 47303, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

MedPharmics

Kenner, Louisiana, 70065, United States

Location

Androscoggin Cardiology Associates / dba Maine Research Associates

Auburn, Maine, 04210, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Genesys Regional Medical Ctr

Grand Blanc, Michigan, 48439, United States

Location

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07103, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Baptist Clinical Research Institute

Memphis, Tennessee, 38120, United States

Location

Michael DeBakey VAMC

Houston, Texas, 77030, United States

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Chum Hotel Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

Montreal General Hospital / MUHC

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Ribose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pentoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Wilson S Colucci, MD

  Boston University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 21, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 14, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); US (20)