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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT02814097 (opens ClinicalTrials.gov in a new tab)Other idSPIHF-203Other id2015-005615-32Other id2015

Overview

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

Germany, Serbia

Start
2 Sept 2016
Primary completion
4 May 2017
Completion
2 Jun 2017
First posted
27 Jun 2016 (estimated)
Last update posted
7 Sept 2017
Conditions
Chronic Heart Failure

Timeline

1 trial · 1 completed

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

    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

    NCT02814097

    2 Sept 2016 to 2 Jun 2017

Registry summary

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

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.

Interventions

  • elamipretideDrug
  • PlaceboDrug

Arms2

  • 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. Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups

    Time frame · 4 weeks

Secondary outcomes(4)
  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

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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: * 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.

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