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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02814097
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : September 7, 2017
Sponsor:
Collaborators:
Charite University, Berlin, Germany
SCIRENT Clinical Research and Science d.o.o.
Information provided by (Responsible Party):
Stealth BioTherapeutics Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: elamipretide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2, 2016
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 40 mg elamipretide
40 mg elamipretide once daily for 28 consecutive days
Drug: elamipretide
Subcutaneous injection of 40 mg elamipretide once daily for 28 consecutive days
Other Names:
  • MTP-131
  • Bendavia

Placebo Comparator: Placebo
Placebo once daily for 28 consecutive days
Drug: Placebo
Subcutaneous injection of placebo administered once daily for 28 consecutive days




Primary Outcome Measures :
  1. Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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:

    a) 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

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814097


Locations
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Germany
Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum
Berlin, Germany, 13353
German Heart Center
Berlin, Germany, 13353
Serbia
Clinical Centre of Serbia, Clinic for Cardiology
Belgrade, Serbia, 11000
Clinical Hospital Center "Dr Dragiša Mišović-Dedinje", Department of Cardiology
Belgrade, Serbia, 11000
Clinical Hospital Center "Zvezdara", Department of Cardiology
Belgrade, Serbia, 11000
Clinical Hospital Center "Bežanijska Kosa", Department of Cardiology
Belgrade, Serbia, 11080
Clinical Hospital Center "Zemun", Department of Cardiology
Belgrade, Serbia, 11080
Clinical Center Niš, Clinic for Cardiology
Niš, Serbia, 18000
Institute for Cardiovascular Diseases Vojvodina, Clinic for Cardiology
Sremska Kamenica, Serbia, 21204
Sponsors and Collaborators
Stealth BioTherapeutics Inc.
Charite University, Berlin, Germany
SCIRENT Clinical Research and Science d.o.o.
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Responsible Party: Stealth BioTherapeutics Inc.
ClinicalTrials.gov Identifier: NCT02814097    
Other Study ID Numbers: SPIHF-203
2015-005615-32 ( EudraCT Number )
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Keywords provided by Stealth BioTherapeutics Inc.:
Heart Failure
HFpEF
elamipretide
MTP-131
Bendavia™
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases