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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

NCTNCT02788747 (opens ClinicalTrials.gov in a new tab)Other idSPIHF-201Other id2014-005724-10Other id2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
71 participants (actual)
Sponsor
Stealth BioTherapeutics Inc. · Industry
Design
Randomized · Triple masking
Countries
3 countries

Italy, Netherlands, United Kingdom

Start
Jun 2016
Primary completion
Sept 2017
Completion
Oct 2017
First posted
2 Jun 2016 (estimated)
Last update posted
14 May 2020
Conditions
Heart Failure

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 2

    Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

    NCT02788747

    Jun 2016 to Oct 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF).

Interventions

  • 4 mg elamipretideDrug
  • 40 mg elamipretideDrug
  • PlaceboDrug

Arms3

  • Experimental

    4 mg elamipretide

    4 mg elamipretide once daily for 28 consecutive days

  • Experimental

    40 mg elamipretide

    40 mg elamipretide once daily for 28 consecutive days

  • Placebo comparator

    Placebo

    Placebo once daily for 28 consecutive days

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Left Ventricular End Systolic Volume (ml)

    Time frame · Baseline to Week 4

    Registry description

    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.

Secondary outcomes(20)

  1. Change in Left Ventricular Ejection Fraction (% of Blood Volume)

    Time frame · Baseline to Week 4

    Registry description

    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.

  2. Change in Left Ventricular End Diastolic Volume (ml) as Measured by MRI

    Time frame · Baseline to Week 4

    Registry description

    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.

  3. Change in Left Ventricular Stroke Volume (ml)

    Time frame · Baseline to Week 4

    Registry description

    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.

  4. Change in Left Ventricular Cardiac Output (L/Min)

    Time frame · Baseline to Week 4

    Registry description

    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.

  5. Change in Left Ventricular Myocardial Mass (g)

    Time frame · Baseline to Week 4

    Registry description

    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.

  6. Change in Right Ventricular End Systolic Volume (mL)

    Time frame · Baseline to Week 4

    Registry description

    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.

  7. Change in Right Ventricular End Diastolic Volume (mL)

    Time frame · Baseline to Week 4

    Registry description

    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.

  8. Change in Right Ventricular Ejection Fraction (% Blood Volume)

    Time frame · Baseline to Week 4

    Registry description

    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.

  9. Change in Early and Late Mitral Inflow Velocity Ratio

    Time frame · Baseline to Week 4

    Registry description

    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.

  10. Change in Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity Ratio (E/e')

    Time frame · Baseline to Week 4

    Registry description

    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.

  11. Change in Left Atrial Volume (mL)

    Time frame · Baseline to Week 4

    Registry description

    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.

  12. Change in Left Ventricular Global Longitudinal Strain Assessment (%)

    Time frame · Baseline to Week 4

    Registry description

    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.

  13. Change in Left Ventricular End Diastolic Volume (mL) as Measured by Echocardiography

    Time frame · Baseline to Week 4

    Registry description

    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.

  14. Change in Left Ventricular End Systolic Volume (mL) as Measured by Echocardiography

    Time frame · Baseline to Week 4

    Registry description

    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.

  15. Change in Biplane Ejection Fraction (mL)

    Time frame · Baseline to Week 4

    Registry description

    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.

  16. Left Ventricular Mass Assessment (g)

    Time frame · Baseline to Week 4

    Registry description

    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.

  17. Change in Tricuspid Regurgitation Severity Assessment (cm²)

    Time frame · Baseline to Week 4

    Registry description

    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.

  18. Change in Right Ventricular Fractional Area (%)

    Time frame · Baseline to Week 4

    Registry description

    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.

  19. Change in Right Ventricular Systolic Pressure (mmHg)

    Time frame · Baseline to Week 4

    Registry description

    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.

  20. Change in Mitral Regurgitation Severity (cm²)

    Time frame · Baseline to Week 4

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline to Week 4

Change in Left Ventricular End Systolic Volume (ml)

GroupValue (mL)Spread
4 mg Elamipretide-4.46.50
40 mg Elamipretide-1.29.04
Placebo-3.85.85
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline to Week 4

Change in Left Ventricular Ejection Fraction (% of Blood Volume)

GroupValue (percentage of blood volume)Spread
4 mg Elamipretide2.22.43
40 mg Elamipretide1.52.82
Placebo2.33.69
Secondary outcomeMean· Baseline to Week 4

Change in Left Ventricular End Diastolic Volume (ml) as Measured by MRI

GroupValue (mL)Spread
4 mg Elamipretide-2.89.50
40 mg Elamipretide0.511.96
Placebo-2.29.77
Secondary outcomeMean· Baseline to Week 4

Change in Left Ventricular Stroke Volume (ml)

GroupValue (mL)Spread
4 mg Elamipretide3.19.23
40 mg Elamipretide3.79.36
Placebo3.013.14
Secondary outcomeMean· Baseline to Week 4

Change in Left Ventricular Cardiac Output (L/Min)

GroupValue (L/min)Spread
4 mg Elamipretide0.211.264
40 mg Elamipretide-0.011.004
Placebo0.270.860
Secondary outcomeMean· Baseline to Week 4

Change in Left Ventricular Myocardial Mass (g)

GroupValue (grams)Spread
4 mg Elamipretide0.02.82
40 mg Elamipretide-0.42.78
Placebo-0.02.26
Secondary outcomeMean· Baseline to Week 4

Change in Right Ventricular End Systolic Volume (mL)

GroupValue (mL)Spread
4 mg Elamipretide-0.94.21
40 mg Elamipretide-0.84.94
Placebo-0.63.72
Secondary outcomeMean· Baseline to Week 4

Change in Right Ventricular End Diastolic Volume (mL)

GroupValue (mL)Spread
4 mg Elamipretide0.59.70
40 mg Elamipretide-1.210.72
Placebo-0.07.61

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
4 mg Elamipretide4 mg elamipretide: subcutaneous injection administered once daily for 28 consecutive days0 / 220 / 229 / 22
40 mg Elamipretide40 mg elamipretide: subcutaneous injection administered once daily for 28 consecutive days0 / 251 / 2516 / 25
PlaceboPlacebo: subcutaneous injection of placebo administered once daily for 28 consecutive days0 / 240 / 2410 / 24

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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. * 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).

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