Evaluation of Vepoloxamer in Chronic Heart Failure

Phase 2

Terminated

• Conditions: Chronic Heart Failure
• Interventions: Other: 5% dextrose in water; Drug: Vepoloxamer

• Registration Number: NCT02596477
• Lead Sponsor: Mast Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-04
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5% dextrose in water (D5W)	5% dextrose in water	D5W administered intravenously over 3 hours
Vepoloxamer - High dose	Vepoloxamer	Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours
Vepoloxamer - Low dose	Vepoloxamer	Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours

Primary Outcome Measures

Name	Time	Method
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 treatment-related adverse events as assessed by CTCAE v 4.03	Study Day 1 to 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 left ventricular end diastolic volume index	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

Trial Locations

Locations (1)

Research Center; 🇦🇺 Melbourne, Victoria, Australia