Evaluation of Vepoloxamer in Chronic Heart Failure

Mast Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Chronic Heart Failure

Treatments: Drug: Vepoloxamer; Other: 5% dextrose in water

Study type: Interventional

Funder types: Industry

Identifiers

NCT02596477

MST-188-09

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 3 patient groups, including a placebo group

Vepoloxamer - Low dose

Experimental group

Description:

Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours

Treatment:

Drug: Vepoloxamer

Vepoloxamer - High dose

Experimental group

Description:

Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours

Treatment:

Drug: Vepoloxamer

5% dextrose in water (D5W)

Placebo Comparator group

Description:

D5W administered intravenously over 3 hours

Treatment:

Other: 5% dextrose in water