Evaluation of Vepoloxamer in Chronic Heart Failure

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02596477

Enrollment

Registered

2015-11-04

Start date

2015-10-31

Completion date

Unknown

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

Heart failure

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.

Interventions

DRUGVepoloxamer

OTHER5% dextrose in water

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026