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 |
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.
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
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