Chronic Heart FailurePhase 2NCT02814097
A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing elamipretide in people with Chronic Heart Failure, run by Stealth BioTherapeutics Inc. at 9 sites in 2 countries.
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4 weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- elamipretide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 2 Sep 2016to 2 Jun 2017
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥45 and <80 years.
- Symptomatic heart failure (i.e. NYHA II or III) due to HFpEF for at least 6 months prior to study start
- Evidence of HFpEF: LVEF ≥45% and E/e´>10 and NT-pro-BNP >220 pg/ml (sinus rhythm) / > 600 pg/mL (atrial fibrillation)
- An exercise-induced increase in E/e' of at least 1.5 units during stress echocardiography assessment.
- Heart failure is considered to be stable, in the judgment of the investigator, and no hospitalization for HFpEF or changes in dose regimen of pharmacologic treatment for HF has occurred within 1 month prior to the Screening Visit.
- Treatment with appropriate pharmacologic therapy to manage underlying risk factors according to current guidelines.
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- Women of childbearing potential must agree to use 1 of the following methods of birth control from the date they sign the ICF until two months after the last dose of study medication:
- Abstinence, b) surgically sterilized male partner, or c) barrier method And hormonal contraception
- Women of child-bearing potential must have a negative serum pregnancy test at baseline
- Willing and able to provide signed informed consent form (ICF) prior to participation in any study-related procedures
Who cannot join
- Probable alternative diagnoses that in the opinion of the investigator could account for the patient's symptoms e.g. severe pulmonary dysfunction or severe asthma
- LVEF <45% (at the moment of enrollment or in medical history)
- Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit.
- Acute coronary syndrome (ACS), stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit.
- Uncontrolled hypertension defined as a systolic blood pressure (BP) >160 mm Hg or a diastolic BP >100 mm Hg on at least 2 consecutive readings that will require a change in anti-hypertensive treatment during the study period.
- Active cancer or undergoing chemotherapy within previous 6 months
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- Total bilirubin >2x the upper limit of normal (ULN) in the absence of Gilbert's Syndrome (M. Meulengracht) and liver enzymes (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] and/or alkaline phosphatase) elevation >3xULN
- Estimated glomerular filtration rate <30 mL/min, by MDRD
- Known active drug or alcohol abuse within 1 year of the Screening Visit.
- Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment
- Treatment with spironolactone or eplerenone for less than 3 months at study start
- Treatment with dabigatran
- Treatment with valsartan/sacubitril
- Female subjects who are pregnant, planning to become pregnant, or lactating.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Serbia7 sites
Clinical Centre of Serbia, Clinic for Cardiology
Belgrade, 11000
Clinical Hospital Center "Dr Dragiša Mišović-Dedinje", Department of Cardiology
Belgrade, 11000
Clinical Hospital Center "Zvezdara", Department of Cardiology
Belgrade, 11000
Clinical Hospital Center "Bežanijska Kosa", Department of Cardiology
Belgrade, 11080
Clinical Hospital Center "Zemun", Department of Cardiology
Belgrade, 11080
Institute for Cardiovascular Diseases Vojvodina, Clinic for Cardiology
Kamenitz, 21204
Clinical Center Niš, Clinic for Cardiology
Niš, 18000
Germany2 sites
Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum
Berlin, 13353
German Heart Center
Berlin, 13353
About this study
Official title: A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4 weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function.
- Conditions
- Chronic Heart Failure
- Being tested
- elamipretide, Placebo
- Keywords
- Heart Failure, HFpEF, elamipretide, MTP-131, Bendavia™
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elamipretideDrug
Also called MTP-131, Bendavia
Subcutaneous injection of 40 mg elamipretide once daily for 28 consecutive days
PlaceboDrug
Subcutaneous injection of placebo administered once daily for 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 40 mg elamipretide | Experimental | 40 mg elamipretide once daily for 28 consecutive days Receives: Drug: elamipretide |
| Placebo | Placebo comparator | Placebo once daily for 28 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups
Measured: 4 weeks
Secondary outcomes (4)
Compare the change at rest and during submaximal stress in LV systolic global longitudinal strain (GLS) between the elamipretide and placebo groups at the end of the 4-week treatment period
Measured: 4 weeks
Compare the change in 6-minute walking distance, between the elamipretide and placebo groups at the end of the 4-week treatment period
Measured: 4 weeks
Compare the change in NT-proBNP, between the elamipretide and placebo groups at the end of the 4-week treatment period
Measured: 4 weeks
Compare the percent of patients on elamipretide versus placebo presenting with TEAEs and SAEs, including changes in biomarkers of myocardial damage and changes in markers of renal function
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start2 Sep 2016
- Primary completion4 May 2017
- Study completion2 Jun 2017
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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stealth BioTherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany, SCIRENT Clinical Research and Science d.o.o.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814097
- Sponsor's protocol ID
- SPIHF-203
- Other IDs
- 2015-005615-32, 2015
- Status last verified
- Sep 2017
- First submitted
- 8 Jun 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT02814097
- Acronym / sponsor ID
- SPIHF-203
- Conditions
- Chronic Heart Failure
- Keywords
- Heart Failure, HFpEF, elamipretide, MTP-131, Bendavia™
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Stealth BioTherapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany, SCIRENT Clinical Research and Science d.o.o.
- Study start
- 2 Sep 2016 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 27 Jun 2016 (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 multi-center, randomized, double-blind, placebo-controlled study in subjects with stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4 weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 mg elamipretide | Experimental | Drug: elamipretide40 mg elamipretide once daily for 28 consecutive days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily for 28 consecutive days |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥45 and <80 years.
- Symptomatic heart failure (i.e. NYHA II or III) due to HFpEF for at least 6 months prior to study start
- Evidence of HFpEF: LVEF ≥45% and E/e´>10 and NT-pro-BNP >220 pg/ml (sinus rhythm) / > 600 pg/mL (atrial fibrillation)
- An exercise-induced increase in E/e' of at least 1.5 units during stress echocardiography assessment.
- Heart failure is considered to be stable, in the judgment of the investigator, and no hospitalization for HFpEF or changes in dose regimen of pharmacologic treatment for HF has occurred within 1 month prior to the Screening Visit.
Key exclusion criteria (14 listed)
- Probable alternative diagnoses that in the opinion of the investigator could account for the patient's symptoms e.g. severe pulmonary dysfunction or severe asthma
- LVEF <45% (at the moment of enrollment or in medical history)
- Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit.
- Acute coronary syndrome (ACS), stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit.
- Uncontrolled hypertension defined as a systolic blood pressure (BP) >160 mm Hg or a diastolic BP >100 mm Hg on at least 2 consecutive readings that will require a change in anti-hypertensive treatment during the study period.
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 |
|---|---|---|
| elamipretideAlso: MTP-131, BendaviaSubcutaneous injection of 40 mg elamipretide once daily for 28 consecutive days | Drug | 40 mg elamipretide |
| PlaceboSubcutaneous injection of placebo administered once daily for 28 consecutive days | Drug | Placebo |
Primary outcome
Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups
Time frame: 4 weeks
4 secondary outcomes
Compare the change at rest and during submaximal stress in LV systolic global longitudinal strain (GLS) between the elamipretide and placebo groups at the end of the 4-week treatment period
Time frame: 4 weeks
Compare the change in 6-minute walking distance, between the elamipretide and placebo groups at the end of the 4-week treatment period
Time frame: 4 weeks
Compare the change in NT-proBNP, between the elamipretide and placebo groups at the end of the 4-week treatment period
Time frame: 4 weeks
Compare the percent of patients on elamipretide versus placebo presenting with TEAEs and SAEs, including changes in biomarkers of myocardial damage and changes in markers of renal function
Time frame: 4 weeks
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 7 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 elamipretide in people with Chronic Heart Failure, run by Stealth BioTherapeutics Inc. at 9 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 10 inclusion and 14 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 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Serbia, Germany. 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 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?
Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups (time frame: 4 weeks). 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 7 Sep 2017.