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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
Subcutaneous injection of 40 mg elamipretide once daily for 28 consecutive days
Subcutaneous injection of placebo administered once daily for 28 consecutive days
Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum
Berlin, Germany
German Heart Center
Berlin, Germany
Clinical Centre of Serbia, Clinic for Cardiology
Belgrade, Serbia
Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups
Time frame: 4 weeks
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Hospital Center "Dr Dragiša Mišović-Dedinje", Department of Cardiology
Belgrade, Serbia
Clinical Hospital Center "Zvezdara", Department of Cardiology
Belgrade, Serbia
Clinical Hospital Center "Bežanijska Kosa", Department of Cardiology
Belgrade, Serbia
Clinical Hospital Center "Zemun", Department of Cardiology
Belgrade, Serbia
Institute for Cardiovascular Diseases Vojvodina, Clinic for Cardiology
Kamenitz, Serbia
Clinical Center Niš, Clinic for Cardiology
Niš, Serbia