Clinical trial NCT01858480: Study To Evaluate D-Ribose For The Treatment of Congestive Heart Failure
Official title: Randomized, Double-Blind, Placebo-Controlled Study To Evaluate D-Ribose For The Treatment Of Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Congestive Heart Failure
Keywords: CHF
Lead sponsor: RiboCor, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Left Ventricular Ejection Fraction (LVEF), measured by transthoracic 2-D echocardiography with contrast
timeFrame: LVEF (by 2-D echocardiography): Change from Baseline to Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Modesto
country: United States
facility: Novo Research, Inc.
state: California
city: Sylmar
country: United States
facility: Olive View-UCLA- Medical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Columbus
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Macon
country: United States
facility: Mercer University - Mercer Medicine
state: Georgia
city: Muncie
country: United States
facility: Medical Consultants PC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Kenner
country: United States
facility: MedPharmics
state: Louisiana
city: Auburn
country: United States
facility: Androscoggin Cardiology Associates / dba Maine Research Associates
state: Maine
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Ctr
state: Michigan
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Clinical Research Institute
state: Tennessee
city: Houston
country: United States
facility: Michael DeBakey VAMC
state: Texas
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Chum Hotel Dieu
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital / MUHC
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Boston University
name: Wilson S Colucci, MD
role: STUDY_CHAIR
References: