Evaluation of Vepoloxamer in Chronic Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical marker and functional benefit to damaged heart muscle cells. This will be evaluated by measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure will be evaluated.

Official Title
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A Phase 2 Randomized, Double-Blind, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vepoloxamer Injection, 22.5% (Sodium-Free) in Ambulatory Subjects With Chronic Heart Failure

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Drug: Vepoloxamer
* Other: 5% dextrose in water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 through 74 Duration of documented heart failure >3 months On stable concomitant medication regimen ≥4 weeks Left ventricular ejection fraction ≤35% Systolic blood pressure ≥90 mmHg Exclusion Criteria: Severe valvular stenosis or primary valvular regurgitation as the cause of heart failure History of myocardial infarction, coronary artery bypass graft surgery, or percutaneous intervention within the prior 3 months Estimated glomerular filtration rate ≤45 mL/min/1.73 m2 Acutely decompensated heart failure within 1 month prior to the screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vepoloxamer - Low dose<br>Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours | Drug: Vepoloxamer<br> <br> |
| Experimental: Vepoloxamer - High dose<br>Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours | Drug: Vepoloxamer<br> <br> |
| Placebo Comparator: 5% dextrose in water (D5W)<br>D5W administered intravenously over 3 hours | Other: 5% dextrose in water<br> <br> * Other names: D5W;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP |  | Study Day 1 through Study Day 30 | 
| Number of subjects with a change in Six Minute Walk test |  | Study Day 1 to Study Day 30 | 
| Number of subjects with a change in Borg dyspnea index |  | Study Day 1 to Study Day 30 | 
| Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire® |  | Study Day 1 to Study Day 30 | 
| Number of subjects with a change in left ventricular end diastolic volume index |  | Study Day 1 to Study Day 30 | 
| Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03 |  | Study Day 1 to Study Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure