Evaluation of Vepoloxamer in Chronic Heart Failure

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mast Therapeutics, Inc.

Criteria

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