NCT02596477

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 30, 2015

Last Update Submit

October 26, 2016

Conditions

Chronic Heart Failure

Keywords

Heart failure

Outcome Measures

Primary Outcomes (6)

  • 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 a change in Six Minute Walk test

    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

  • Number of subjects with a change in left ventricular end diastolic volume index

    Study Day 1 to 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

Study Arms (3)

Vepoloxamer - Low dose

EXPERIMENTAL

Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours

Drug: Vepoloxamer

Vepoloxamer - High dose

EXPERIMENTAL

Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours

Drug: Vepoloxamer

5% dextrose in water (D5W)

PLACEBO COMPARATOR

D5W administered intravenously over 3 hours

Other: 5% dextrose in water

Interventions

VepoloxamerDRUG
Vepoloxamer - High doseVepoloxamer - Low dose
5% dextrose in waterOTHER
Also known as: D5W
5% dextrose in water (D5W)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Center

Detroit, Michigan, 48202, United States

Location

Research Center

Tupelo, Mississippi, 38801, United States

Location

Research Center

Cardiff, New South Wales, 2285, Australia

Location

Research Center

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Heart Failure

Interventions

GlucoseWater

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Edwin L. Parsley, D.O.

    Mast Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 4, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

AU(2)US(2)