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Evaluation of Vepoloxamer in Chronic Heart Failure

This study has been terminated.
(Terminated for administrative reasons not related to safety or efficacy)
Sponsor:
Information provided by (Responsible Party):
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02596477
First received: October 30, 2015
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Chronic Heart Failure Drug: Vepoloxamer Other: 5% dextrose in water Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Mast Therapeutics, Inc.:

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

Enrollment: 10
Study Start Date: October 2015
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02596477

Locations
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
Study Director: Edwin L. Parsley, D.O. Mast Therapeutics, Inc.
  More Information

Responsible Party: Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02596477     History of Changes
Other Study ID Numbers: MST-188-09
Study First Received: October 30, 2015
Last Updated: October 26, 2016

Keywords provided by Mast Therapeutics, Inc.:
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 26, 2017