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Evaluation of Vepoloxamer in Chronic Heart Failure

Primary Purpose

Chronic Heart Failure

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vepoloxamer
5% dextrose in water
Sponsored by
Mast Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Heart failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Center
  • Research Center
  • Research Center
  • Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Vepoloxamer - Low dose

Vepoloxamer - High dose

5% dextrose in water (D5W)

Arm Description

Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours

Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours

D5W administered intravenously over 3 hours

Outcomes

Primary Outcome Measures

Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP
Number of subjects with a change in Six Minute Walk test
Number of subjects with a change in Borg dyspnea index
Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire®
Number of subjects with a change in left ventricular end diastolic volume index
Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03

Secondary Outcome Measures

Full Information

First Posted
October 30, 2015
Last Updated
October 26, 2016
Sponsor
Mast Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02596477
Brief Title
Evaluation of Vepoloxamer in Chronic Heart Failure
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Terminated for administrative reasons not related to safety or efficacy
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mast Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vepoloxamer - Low dose
Arm Type
Experimental
Arm Description
Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours
Arm Title
Vepoloxamer - High dose
Arm Type
Experimental
Arm Description
Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours
Arm Title
5% dextrose in water (D5W)
Arm Type
Placebo Comparator
Arm Description
D5W administered intravenously over 3 hours
Intervention Type
Drug
Intervention Name(s)
Vepoloxamer
Intervention Type
Other
Intervention Name(s)
5% dextrose in water
Other Intervention Name(s)
D5W
Primary Outcome Measure Information:
Title
Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP
Time Frame
Study Day 1 through Study Day 30
Title
Number of subjects with a change in Six Minute Walk test
Time Frame
Study Day 1 to Study Day 30
Title
Number of subjects with a change in Borg dyspnea index
Time Frame
Study Day 1 to Study Day 30
Title
Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire®
Time Frame
Study Day 1 to Study Day 30
Title
Number of subjects with a change in left ventricular end diastolic volume index
Time Frame
Study Day 1 to Study Day 30
Title
Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03
Time Frame
Study Day 1 to Study Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin L. Parsley, D.O.
Organizational Affiliation
Mast Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Research Center
City
Cardiff
State/Province
New South Wales
ZIP/Postal Code
2285
Country
Australia
Facility Name
Research Center
City
Melbourne
State/Province
Victoria
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Vepoloxamer in Chronic Heart Failure

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