Effect of Multi injections of Elamipretide on Patients with Chronic HF

  • Research type

    Research Study

  • Full 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

  • IRAS ID

    201904

  • Contact name

    Jim Carr

  • Contact email

    Jim.Carr@stealthbt.com

  • Eudract number

    2014-005724-10

  • Duration of Study in the UK

    1 years, 0 months, 30 days

  • Research summary

    This research study is designed to determine if multiple subcutaneous injections of the study drug at different doses; has any effect on heart function in patients with chronic heart disease; is safe to take; how well it can be tolerated
    This study will also:
    Investigate how much of the study drug gets into the blood stream
    Assess whether the study drug has an impact on quality of life
    Explore the effects of the study drug on a certain component of the blood, called N-terminal pro-brain natriuretic peptide NT-pro-BNP, which may indicate how well the heart is working

  • REC name

    South Central - Hampshire B Research Ethics Committee

  • REC reference

    16/SC/0275

  • Date of REC Opinion

    9 Aug 2016

  • REC opinion

    Further Information Favourable Opinion