Heart FailurePhase 2NCT02788747
Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction
A Phase 2 study testing 4 mg elamipretide and 40 mg elamipretide in people with Heart Failure, run by Stealth BioTherapeutics Inc. at 15 sites in 3 countries.
Trial summary
This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- 4 mg elamipretide and 40 mg elamipretide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Jun 2016to Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Willing and able to provide signed informed consent form (ICF) prior to participation in any study-related procedures.
- Age ≥40 and ≤80 years.
- A known history of chronic ischemic or non-ischemic cardiomyopathy of at least 6 months duration from the time of the initial diagnosis.
- Receiving heart failure (HF) treatment, including, but not limited to, angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin receptor blockers (ARB), and an evidence-based beta blocker for the treatment of HF. Subjects who cannot tolerate ACEI or ARB due to reduced renal function or hypotension are eligible. Subjects may be receiving aldosterone antagonists, but this is not a requirement for the study.
- HF is considered to be stable in the judgment of the Investigator AND doses of HF treatment have been stable for at least 1 month prior to the Screening Visit.
- In normal sinus rhythm (electrocardiogram documented) at Screening and Day 1 and no history of atrial fibrillation in the past 12 months
Show all 11Show fewer
- No hospitalization related to HF within 1 month prior to the Screening Visit.
- Left Ventricular Ejection Fraction (LVEF) ≤ 40% by 2-D echocardiography at Screening.
- At least 3 viable segments (hyperenhancement ≤ 25%) by a qualifying delayed gadolinium-enhanced cardiac MRI examination at Screening (confirmed by independent core lab).
- 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, maintenance of monogamous relationship with a male partner who has been surgically sterilized by vasectomy, or barrier method AND either hormonal contraception or an intrauterine device or system.
Who cannot join
- History of any concurrent medical condition which, in the opinion of the Investigator, significantly increased the potential risks associated with administration of study medication or any other aspect of study participation.
- Any contraindication to MRI scanning.
- Left ventricular end diastolic dimension (LVEDD) indexed to Body Surface Area is > 45 mm/m2.
- Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit.
- Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit.
- Obstructive or restrictive cardiomyopathy, infiltrative diseases of the myocardium (e.g., amyloid, sarcoid, etc.) myocarditis, or reductions in LV function thought to be secondary primarily to valvular heart disease, prior cardiac valve surgery or known aortic stenosis.
Show all 26Show fewer
- The presence or anticipated placement of any pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) devices during the ensuing 6-week study period.
- Presence of second degree or advanced heart block.
- Uncontrolled hypertension defined as a systolic blood pressure > 160 mmHg or a diastolic blood pressure > 110 mmHg on at least two consecutive readings.
- Presence of any left ventricular thrombus, pericardial disease, uncorrected thyroid disease or a dyskinetic left ventricular aneurysm.
- History of cancer that causes symptoms, disabilities, or is likely to lead to hospitalization or treatment in the next 12 months.
- Currently receiving treatment with chemotherapeutic agents or immunosuppressant agents or has received prior radiation therapy to the chest.
- Liver enzymes (alanine aminotransferase [ALT] AND/OR aspartate. aminotransferase [AST]) elevation > 3 times the upper limit of normal (ULN).
- Total bilirubin > 1.5 times ULN in the absence of Gilbert's Syndrome.
- Bleeding diathesis or any known blood dyscrasia.
- Anemia, defined as hemoglobin < 9 g/dL or planned blood transfusions in the next 6 weeks.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min, using the Modification of Diet in Renal Disease (MDRD) Study equation.
- History of hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection, or diagnosis of immunodeficiency.
- Known active drug or alcohol abuse within 1 year of the Screening Visit. Alcohol abuse is defined as 15 or more drinks for men per week or 8 or more for women.
- Recipient of any investigational drugs, stem cell or gene therapies, or devices OR participation in another clinical trial, within 3 months prior to the Screening Visit.
- Female subjects who are pregnant, planning to become pregnant, or lactating.
- Requiring any change in doses of cardiovascular medication (including diuretics) in order to control worsening of HF symptoms.
- Known allergy to gadolinium.
- Currently receiving treatment with therapeutic doses of anticoagulants. Antiplatelet therapy used to prevent cardiovascular disease (primary prevention) or to treat chronic disease (secondary prevention) is permitted.
- Currently receiving treatment with sacubitril/valsartan or trimetazidine.
- Hyponatremia defined as plasma Na+ level <125 mEq/L (UK only).
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
Italy8 sites
A.O. Papa Giovanni XXIII Cardiologia 1, Torre 5
Bergamo, 24127
A.O. Spedali Civili di Brescia Cardiologia
Brescia, 25123
Azienda Ospedaliera Brotzu Cardiologia
Cagliari, 09134
Centro Cardiologico Monzino U.O. Scompenso, Cardiologia Clinica e Cardiologia Riabilitativa
Milan, 20138
Ospedale Niguarda Ca' Granda SC Cardiologia 2
Milan, 20162
Cardiologia clinica, Unità dello Scompenso e Terapia intensive Reparto Carlo Magno, Faggi Policlinico di Monza
Monza, 20900
Dip. Cardiotoracovascolare: Cardiologia Fondazione IRCCS Policlinico San Matteo Pad. Nuovo Ospedale "DEA" Degenza: PIANO +3 Ambulatori: P.T. e P+3
Pavia, 27100
Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanità Pubblica
Pisa, 56124
Netherlands5 sites
Deventer Hospital, Department of Cardiology
Deventer, 7416 SE
University Medical Centre Groningen
Groningen, 9713 GZ
Anthonius Ziekenhuis, Cardiology Department
Sneek, 8601 ZK
Elisabeth Twee Steden Hospital (ETZ), Department of Cardiology
Tilburg, 5022 GC
Gelre Ziekenhuis Zutphen, Department of Cardiology
Zutphen, 7207 AE
United Kingdom2 sites
Ninewells Hospital and Medical School
Dundee, DDI 9SY
William Harvey Heart Centre CRC, (Barts Health NHS Trust)
London, EC1M 6BQ
About this study
Official title: A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of Multiple Subcutaneous Injections of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction
This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF).
Read the detailed description
This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF). After completing the Screening period, a total of 71 subjects were randomized, in a 1:1:1 ratio, to receive either placebo, 4 mg elamipretide, or 40 mg elamipretide once daily for 28 consecutive days.
Each treatment group went through 3 distinct periods: Screening, Treatment, and Follow up.
- Conditions
- Heart Failure
- Being tested
- 4 mg elamipretide, 40 mg elamipretide, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mg elamipretideDrug
Also called MTP-131, Bendavia
Subcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days
40 mg elamipretideDrug
Also called MTP-131, Bendavia
Subcutaneous injection of 40 mg elamipretide administered once daily for 28 consecutive days
PlaceboDrug
Subcutaneous injection of placebo administered once daily for 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 4 mg elamipretide | Experimental | 4 mg elamipretide once daily for 28 consecutive days Receives: Drug: 4 mg elamipretide |
| 40 mg elamipretide | Experimental | 40 mg elamipretide once daily for 28 consecutive days Receives: Drug: 40 mg 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.
Change in Left Ventricular End Systolic Volume (ml)
Change in left ventricular end systolic volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Measured: Baseline to Week 4
Secondary outcomes (20)
Change in Left Ventricular Ejection Fraction (% of Blood Volume)
Change in Left Ventricular Ejection Fraction as measured by percentage of blood volume from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Measured: Baseline to Week 4
Change in Left Ventricular End Diastolic Volume (ml) as Measured by MRI
Change from baseline in Left Ventricular End Diastolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Measured: Baseline to Week 4
Change in Left Ventricular Stroke Volume (ml)
Change in Left Ventricular Stroke Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Measured: Baseline to Week 4
Change in Left Ventricular Cardiac Output (L/Min)
Change in Left Ventricular Cardiac Output as measured by L/min from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Measured: Baseline to Week 4
Change in Left Ventricular Myocardial Mass (g)
Change in Left Ventricular Myocardial Mass as measured by grams from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Measured: Baseline to Week 4
Change in Right Ventricular End Systolic Volume (mL)
Change in Right Ventricular End Systolic Volume as measured by mL from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Measured: Baseline to Week 4
Change in Right Ventricular End Diastolic Volume (mL)
Change in Right Ventricular End Diastolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Measured: Baseline to Week 4
Change in Right Ventricular Ejection Fraction (% Blood Volume)
Change in Right Ventricular Ejection Fraction as measured by percentage of blood volume from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
Measured: Baseline to Week 4
Change in Early and Late Mitral Inflow Velocity Ratio
Change in Early and Late Mitral Inflow Velocity Ratio from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Change in Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity Ratio (E/e')
Change in Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity Ratio as measured by E/e' from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Change in Left Atrial Volume (mL)
Change in Left Atrial Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Change in Left Ventricular Global Longitudinal Strain Assessment (%)
Change in Left Ventricular Global Longitudinal Strain Assessment as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Change in Left Ventricular End Diastolic Volume (mL) as Measured by Echocardiography
Change in Left Ventricular End Diastolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Change in Left Ventricular End Systolic Volume (mL) as Measured by Echocardiography
Change in Left Ventricular End Systolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Change in Biplane Ejection Fraction (mL)
Change in Biplane Ejection Fraction as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Left Ventricular Mass Assessment (g)
Change in Left Ventricular Mass Assessment as measured by grams from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Change in Tricuspid Regurgitation Severity Assessment (cm²)
Change in Tricuspid Regurgitation Severity Assessment as measured by cm from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Change in Right Ventricular Fractional Area (%)
Change Right Ventricular Fractional Area in as measured by percentage from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Change in Right Ventricular Systolic Pressure (mmHg)
Change in Change in Right Ventricular Systolic Pressure as measured by mmHg from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Change in Mitral Regurgitation Severity (cm²)
Change in Mitral Regurgitation Severity as measured by cm² from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stealth BioTherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerasimos Filippatos, MD, Study chair, University of Athens, School of Medicine, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788747
- Sponsor's protocol ID
- SPIHF-201
- Other IDs
- 2014-005724-10, 2014
- Status last verified
- Apr 2020
- First submitted
- 27 May 2016
- Last updated
- 14 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. 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 Multiple Subcutaneous Injections of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT02788747
- Acronym / sponsor ID
- SPIHF-201
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Stealth BioTherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Posted 22 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF).
Detailed description
This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF). After completing the Screening period, a total of 71 subjects were randomized, in a 1:1:1 ratio, to receive either placebo, 4 mg elamipretide, or 40 mg elamipretide once daily for 28 consecutive days.
Each treatment group went through 3 distinct periods: Screening, Treatment, and Follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 mg elamipretide | Experimental | Drug: 4 mg elamipretide4 mg elamipretide once daily for 28 consecutive days |
| 40 mg elamipretide | Experimental | Drug: 40 mg 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 (11 listed)
- Willing and able to provide signed informed consent form (ICF) prior to participation in any study-related procedures.
- Age ≥40 and ≤80 years.
- A known history of chronic ischemic or non-ischemic cardiomyopathy of at least 6 months duration from the time of the initial diagnosis.
- Receiving heart failure (HF) treatment, including, but not limited to, angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin receptor blockers (ARB), and an evidence-based beta blocker for the treatment of HF. Subjects who cannot tolerate ACEI or ARB due to reduced renal function or hypotension are eligible. Subjects may be receiving aldosterone antagonists, but this is not a requirement for the study.
- HF is considered to be stable in the judgment of the Investigator AND doses of HF treatment have been stable for at least 1 month prior to the Screening Visit.
Key exclusion criteria (26 listed)
- History of any concurrent medical condition which, in the opinion of the Investigator, significantly increased the potential risks associated with administration of study medication or any other aspect of study participation.
- Any contraindication to MRI scanning.
- Left ventricular end diastolic dimension (LVEDD) indexed to Body Surface Area is > 45 mm/m2.
- Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit.
- Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 3 months 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 |
|---|---|---|
| 4 mg elamipretideAlso: MTP-131, BendaviaSubcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days | Drug | 4 mg elamipretide |
| 40 mg elamipretideAlso: MTP-131, BendaviaSubcutaneous injection of 40 mg elamipretide administered 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
Change in Left Ventricular End Systolic Volume (ml)
Time frame: Baseline to Week 4
Change in left ventricular end systolic volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.
20 secondary outcomes
Change in Left Ventricular Ejection Fraction (% of Blood Volume)
Time frame: Baseline to Week 4
Change in Left Ventricular End Diastolic Volume (ml) as Measured by MRI
Time frame: Baseline to Week 4
Change in Left Ventricular Stroke Volume (ml)
Time frame: Baseline to Week 4
Change in Left Ventricular Cardiac Output (L/Min)
Time frame: Baseline to Week 4
Change in Left Ventricular Myocardial Mass (g)
Time frame: Baseline to Week 4
Change in Right Ventricular End Systolic Volume (mL)
Time frame: Baseline to Week 4
Change in Right Ventricular End Diastolic Volume (mL)
Time frame: Baseline to Week 4
Change in Right Ventricular Ejection Fraction (% Blood Volume)
Time frame: Baseline to Week 4
Change in Early and Late Mitral Inflow Velocity Ratio
Time frame: Baseline to Week 4
Change in Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity Ratio (E/e')
Time frame: Baseline to Week 4
Change in Left Atrial Volume (mL)
Time frame: Baseline to Week 4
Change in Left Ventricular Global Longitudinal Strain Assessment (%)
Time frame: Baseline to Week 4
Change in Left Ventricular End Diastolic Volume (mL) as Measured by Echocardiography
Time frame: Baseline to Week 4
Change in Left Ventricular End Systolic Volume (mL) as Measured by Echocardiography
Time frame: Baseline to Week 4
Change in Biplane Ejection Fraction (mL)
Time frame: Baseline to Week 4
Left Ventricular Mass Assessment (g)
Time frame: Baseline to Week 4
Change in Tricuspid Regurgitation Severity Assessment (cm²)
Time frame: Baseline to Week 4
Change in Right Ventricular Fractional Area (%)
Time frame: Baseline to Week 4
Change in Right Ventricular Systolic Pressure (mmHg)
Time frame: Baseline to Week 4
Change in Mitral Regurgitation Severity (cm²)
Time frame: Baseline to Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gerasimos Filippatos, MD study chair
University of Athens, School of Medicine, Athens, Greece
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4 mg elamipretide and 40 mg elamipretide in people with Heart Failure, run by Stealth BioTherapeutics Inc. at 15 sites in 3 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 11 inclusion and 26 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, Netherlands, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Left Ventricular End Systolic Volume (ml) (time frame: Baseline to Week 4). 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 14 May 2020.