Evaluation of Vepoloxamer in Chronic Heart Failure

Chronic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02596477
• Other study ID #: MST-188-09
• Status: Terminated
• Phase: Phase 2
• First received: October 30, 2015
• Last updated: October 26, 2016
• Start date: October 2015

Study information

• Verified date: October 2016
• Source: Mast Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Vepoloxamer

Other:
• 5% dextrose in water

Locations

Country	Name	City	State
Australia	Research Center	Cardiff	New South Wales
Australia	Research Center	Melbourne	Victoria
United States	Research Center	Detroit	Michigan
United States	Research Center	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Mast Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP		Study Day 1 through Study Day 30	No
Primary	Number of subjects with a change in Six Minute Walk test		Study Day 1 to Study Day 30	No
Primary	Number of subjects with a change in Borg dyspnea index		Study Day 1 to Study Day 30	No
Primary	Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire®		Study Day 1 to Study Day 30	Yes
Primary	Number of subjects with a change in left ventricular end diastolic volume index		Study Day 1 to Study Day 30	No
Primary	Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03		Study Day 1 to Study Day 30	Yes