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Evaluation of Vepoloxamer in Chronic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02596477
Recruitment Status : Terminated (Terminated for administrative reasons not related to safety or efficacy)
First Posted : November 4, 2015
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Vepoloxamer Other: 5% dextrose in water Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2015
Actual Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Vepoloxamer - Low dose
Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours
Drug: Vepoloxamer
Experimental: Vepoloxamer - High dose
Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours
Drug: Vepoloxamer
Placebo Comparator: 5% dextrose in water (D5W)
D5W administered intravenously over 3 hours
Other: 5% dextrose in water
Other Name: D5W




Primary Outcome Measures :
  1. 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 ]
  2. Number of subjects with a change in Six Minute Walk test [ Time Frame: Study Day 1 to Study Day 30 ]
  3. Number of subjects with a change in Borg dyspnea index [ Time Frame: Study Day 1 to Study Day 30 ]
  4. Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire® [ Time Frame: Study Day 1 to Study Day 30 ]
  5. Number of subjects with a change in left ventricular end diastolic volume index [ Time Frame: Study Day 1 to Study Day 30 ]
  6. Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03 [ Time Frame: Study Day 1 to Study Day 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596477


Locations
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United States, Michigan
Research Center
Detroit, Michigan, United States, 48202
United States, Mississippi
Research Center
Tupelo, Mississippi, United States, 38801
Australia, New South Wales
Research Center
Cardiff, New South Wales, Australia, 2285
Australia, Victoria
Research Center
Melbourne, Victoria, Australia
Sponsors and Collaborators
Mast Therapeutics, Inc.
Investigators
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Study Director: Edwin L. Parsley, D.O. Mast Therapeutics, Inc.
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Responsible Party: Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02596477    
Other Study ID Numbers: MST-188-09
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by Mast Therapeutics, Inc.:
Heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases