Evaluation of Vepoloxamer in Chronic Heart Failure



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:October 2015
Contact:Mast Therapeutics CT.gov Call Center
Phone:1-844-514-2671

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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

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.


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
We found this trial at
3
sites
Cardiff, New South Wales CF14 4ED
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Cardiff,
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5766 Trumbull Avenue
Detroit, Michigan 48236
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Detroit, MI
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Tupelo, Mississippi 38801
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Tupelo, MS
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