Evaluation of Vepoloxamer in Chronic Heart Failure

NCT ID: NCT02596477

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Brief Summary

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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

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Conditions

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Chronic Heart Failure

Keywords

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Heart failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vepoloxamer - Low dose

Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours

Group Type EXPERIMENTAL

Vepoloxamer

Intervention Type DRUG

Vepoloxamer - High dose

Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours

Group Type EXPERIMENTAL

Vepoloxamer

Intervention Type DRUG

5% dextrose in water (D5W)

D5W administered intravenously over 3 hours

Group Type PLACEBO_COMPARATOR

5% dextrose in water

Intervention Type OTHER

Interventions

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Vepoloxamer

Intervention Type DRUG

5% dextrose in water

Intervention Type OTHER

Other Intervention Names

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D5W

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mast Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edwin L. Parsley, D.O.

Role: STUDY_DIRECTOR

Mast Therapeutics, Inc.

Locations

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Research Center

Detroit, Michigan, United States

Site Status

Research Center

Tupelo, Mississippi, United States

Site Status

Research Center

Cardiff, New South Wales, Australia

Site Status

Research Center

Melbourne, Victoria, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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MST-188-09

Identifier Type: -

Identifier Source: org_study_id