Chronic Heart FailurePhase 2NCT02596477
Evaluation of Vepoloxamer in Chronic Heart Failure
A Phase 2 study testing Vepoloxamer and 5% dextrose in water in people with Chronic Heart Failure, run by Mast Therapeutics, Inc. at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Vepoloxamer and 5% dextrose in water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2015to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Research Center
Detroit, Michigan, 48202
Research Center
Tupelo, Mississippi, 38801
Australia2 sites
Research Center
Cardiff, New South Wales, 2285
Research Center
Melbourne, Victoria
About this study
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
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.
- Conditions
- Chronic Heart Failure
- Being tested
- Vepoloxamer, 5% dextrose in water
- Keywords
- Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VepoloxamerDrug
5% dextrose in waterOther
Also called D5W
| Study group | Role | What they receive |
|---|---|---|
| Vepoloxamer - Low dose | Experimental | Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours Receives: Drug: Vepoloxamer |
| Vepoloxamer - High dose | Experimental | Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours Receives: Drug: Vepoloxamer |
| 5% dextrose in water (D5W) | Placebo comparator | D5W administered intravenously over 3 hours Receives: Other: 5% dextrose in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP
Measured: Study Day 1 through Study Day 30
Number of subjects with a change in Six Minute Walk test
Measured: Study Day 1 to Study Day 30
Number of subjects with a change in Borg dyspnea index
Measured: Study Day 1 to Study Day 30
Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire®
Measured: Study Day 1 to Study Day 30
Number of subjects with a change in left ventricular end diastolic volume index
Measured: Study Day 1 to Study Day 30
Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03
Measured: Study Day 1 to Study Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016
Why it stopped: Terminated for administrative reasons not related to safety or efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mast Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edwin L. Parsley, D.O., Study director, Mast Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596477
- Sponsor's protocol ID
- MST-188-09
- Status last verified
- Oct 2016
- First submitted
- 30 Oct 2015
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02596477
- Acronym / sponsor ID
- MST-188-09
- Conditions
- Chronic Heart Failure
- Keywords
- Heart failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated for administrative reasons not related to safety or efficacy
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mast Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vepoloxamer - Low dose | Experimental | Drug: VepoloxamerVepoloxamer injection administered intravenously 225 mg/kg over 3 hours |
| Vepoloxamer - High dose | Experimental | Drug: VepoloxamerVepoloxamer injection administered intravenously 450 mg/kg over 3 hours |
| 5% dextrose in water (D5W) | Placebo comparator | Other: 5% dextrose in waterD5W administered intravenously over 3 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vepoloxamer | Drug | Vepoloxamer - High dose, Vepoloxamer - Low dose |
| 5% dextrose in waterAlso: D5W | Other | 5% dextrose in water (D5W) |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Terminated for administrative reasons not related to safety or efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
Related trials for Chronic Heart Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin L. Parsley, D.O. study director
Mast Therapeutics, Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vepoloxamer and 5% dextrose in water in people with Chronic Heart Failure, run by Mast Therapeutics, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated for administrative reasons not related to safety or efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.