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

Congestive Heart Failure Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled Study To Evaluate D-Ribose For The Treatment Of Congestive Heart Failure

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01858480
• Other study ID #: RC 04C 010
• Status: Withdrawn
• Phase: Phase 2
• First received: May 9, 2013
• Last updated: July 12, 2016
• Start date: July 2013
• Est. completion date: November 2013

Study information

• Verified date: July 2016
• Source: RiboCor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• D-ribose
D-ribose powder for oral solution and D-ribose for injection.

Other:
• Placebo
Placebo dosage form designed to mock active.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
RiboCor, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes