Congestive Heart FailurePhase 1NCT02388464
A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure
A Phase 1 study testing MTP-131 in people with Congestive Heart Failure, run by Stealth BioTherapeutics Inc. at 1 site in Bulgaria.
Trial summary
This is a Phase 1, single-center, randomized, double-blind, single ascending dose, placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- MTP-131
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBulgaria
- Study dates
- Jul 2014to Jun 2015
- Phase
- Phase 1
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic ischemic or non-ischemic cardiomyopathy of at least 6 months duration from the time of the initial diagnosis.
- LVEF ≤35% by 2-D echocardiogram.
- Diagnosis of NYHA Class II or III HF for a minimum of 6 months prior to the Screening Visit.
- HF is considered to be stable and no hospitalization for HF has occurred within the previous 3 months prior to the Screening visit.
- Treatment with appropriate pharmacologic therapy for HF including, but not limited to, angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB), and an evidence-based beta blocker for the treatment of HF (i.e. carvedilol, bisoprolol, or extended-release metoprolol).
- Dose and dose regimen of pharmacologic treatments for HF must be stable for a minimum of 1 month prior to the Screening Visit.
- Females of child-bearing potential must have a negative serum pregnancy test at the Screening Visit and Day 1.
Who cannot join
- LV end-diastolic dimension (LVEDD), by the same method as qualifying LVEF, is >80 mm or LVEDD indexed to body surface area is >0.45.
- Unstable angina pectoris within 1 month before initiation of screening procedures. Unstable angina is defined as the occurrence of chest pain more frequently than usual, pain at rest or upon minimal exertion, or protracted episodes of pain without any discernible trigger, and/or chest pain that persists despite use of vasodilatory therapy (e.g., nitroglycerin).
- Coronary or peripheral artery revascularization procedure within 2 months prior to the Screening Visit.
- An acute myocardial infarction within 3 months prior to the Screening Visit.
- Placement of an automated implantable cardioverter defibrillator (AICD) or any hardware associated with resynchronization therapy.
- Atrial fibrillation at the Screening or Baseline Visits.
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- Uncontrolled hypertension defined as a systolic blood pressure (BP) > 180 mm Hg or a diastolic BP >110 mm Hg on at least 2 consecutive readings.
- Requirement for valve or other cardiac surgery
- Cardiac surgery or valvuloplasty within 2 months prior to the Screening Visit.
- General surgery within 1 month prior to the Screening Visit
- Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic left ventricular aneurysm.
- Cerebrovascular accident or transient ischemic attack within 3 months prior to the Screening Visit.
- Estimated glomerular filtration rate (eGFR) <40 mL/min, using the Modification of Diet in Renal Disease (MDRD) Study equation
- Serologic evidence of hepatitis B or C infection.
- Known acquired immunodeficiency syndrome or HIV-positive status, or diagnosis of immunodeficiency.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Pharmacology Study of the Effects of a Single 4 Hour Intravenous Infusion of Bendavia™ (MTP-131) in Subjects With Stable New York Heart Association Class II-III Congestive Heart Failure Due to Left Ventricular Systolic Dysfunction
This is a Phase 1, single-center, randomized, double-blind, single ascending dose, placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of Bendavia™ (MTP-131).
- Conditions
- Congestive Heart Failure
- Being tested
- MTP-131, Placebo
- Keywords
- Congestive Heart Failure, Bendavia™, MTP-131
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTP-131Drug
MTP-131 (low dose) administered as single intravenous infusion over 4 hours
MTP-131Drug
MTP-131 (intermediate dose) administered as single intravenous infusion over 4 hours
MTP-131Drug
MTP-131 (high dose) administered as single intravenous infusion over 4 hours
PlaceboDrug
Placebo Comparator (at each dose cohort) administered as single intravenous infusion over 4 hours
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: MTP-131 |
| Intermediate dose | Experimental | Not described Receives: Drug: MTP-131 |
| High dose | Experimental | Not described Receives: Drug: MTP-131 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: Assessed up to Day 7
Secondary outcomes (1)
Left ventricular ejection fraction assessed by 2-D echocardiography
Measured: Assessed up to 24 hours post-infusion start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stealth BioTherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Carr, PharmD, Study director, Mighty Therapeutics, Inc.Sotir Marchev, MD,PhD, FESC, Principal investigator, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388464
- Sponsor's protocol ID
- SPIHF-101
- Status last verified
- Sep 2015
- First submitted
- 1 Mar 2015
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Daubert MA, Yow E, Dunn G, Marchev S, Barnhart H, Douglas PS, O'Connor C, Goldstein S, Udelson JE, Sabbah HN. Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide. Circ Heart Fail. 2017 Dec;10(12):e004389. doi: 10.1161/CIRCHEARTFAILURE.117.004389.
PubMed 29217757
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Pharmacology Study of the Effects of a Single 4 Hour Intravenous Infusion of Bendavia™ (MTP-131) in Subjects With Stable New York Heart Association Class II-III Congestive Heart Failure Due to Left Ventricular Systolic Dysfunction
- ClinicalTrials.gov ID
- NCT02388464
- Acronym / sponsor ID
- SPIHF-101
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Bendavia™, MTP-131
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Stealth BioTherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Mar 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.
This is a Phase 1, single-center, randomized, double-blind, single ascending dose, placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of Bendavia™ (MTP-131).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: MTP-131 |
| Intermediate dose | Experimental | Drug: MTP-131 |
| High dose | Experimental | Drug: MTP-131 |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic ischemic or non-ischemic cardiomyopathy of at least 6 months duration from the time of the initial diagnosis.
- LVEF ≤35% by 2-D echocardiogram.
- Diagnosis of NYHA Class II or III HF for a minimum of 6 months prior to the Screening Visit.
- HF is considered to be stable and no hospitalization for HF has occurred within the previous 3 months prior to the Screening visit.
- Treatment with appropriate pharmacologic therapy for HF including, but not limited to, angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB), and an evidence-based beta blocker for the treatment of HF (i.e. carvedilol, bisoprolol, or extended-release metoprolol).
Key exclusion criteria (16 listed)
- LV end-diastolic dimension (LVEDD), by the same method as qualifying LVEF, is >80 mm or LVEDD indexed to body surface area is >0.45.
- Unstable angina pectoris within 1 month before initiation of screening procedures. Unstable angina is defined as the occurrence of chest pain more frequently than usual, pain at rest or upon minimal exertion, or protracted episodes of pain without any discernible trigger, and/or chest pain that persists despite use of vasodilatory therapy (e.g., nitroglycerin).
- Coronary or peripheral artery revascularization procedure within 2 months prior to the Screening Visit.
- An acute myocardial infarction within 3 months prior to the Screening Visit.
- Placement of an automated implantable cardioverter defibrillator (AICD) or any hardware associated with resynchronization therapy.
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 |
|---|---|---|
| MTP-131MTP-131 (low dose) administered as single intravenous infusion over 4 hours | Drug | Low dose |
| MTP-131MTP-131 (intermediate dose) administered as single intravenous infusion over 4 hours | Drug | Intermediate dose |
| MTP-131MTP-131 (high dose) administered as single intravenous infusion over 4 hours | Drug | High dose |
| PlaceboPlacebo Comparator (at each dose cohort) administered as single intravenous infusion over 4 hours | Drug | Placebo |
Primary outcome
Incidence of Adverse Events
Time frame: Assessed up to Day 7
1 secondary outcome
Left ventricular ejection fraction assessed by 2-D echocardiography
Time frame: Assessed up to 24 hours post-infusion start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Derived from this study: PubMed 29217757Daubert MA, Yow E, Dunn G, Marchev S, Barnhart H, Douglas PS, O'Connor C, Goldstein S, Udelson JE, Sabbah HN. Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide. Circ Heart Fail. 2017 Dec;10(12):e004389. doi: 10.1161/CIRCHEARTFAILURE.117.004389.
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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.
Jim Carr, PharmD study director
Mighty Therapeutics, Inc.
Sotir Marchev, MD,PhD, FESC principal investigator
Bulgaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MTP-131 in people with Congestive Heart Failure, run by Stealth BioTherapeutics Inc. at 1 site in Bulgaria.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Adverse Events (time frame: Assessed up to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02388464, which also lists 1 linked publication.
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 17 Sep 2015.