PMID- 32068002
OWN - NLM
STAT- MEDLINE
DCOM- 20210818
LR  - 20210818
IS  - 1532-8414 (Electronic)
IS  - 1071-9164 (Linking)
VI  - 26
IP  - 5
DP  - 2020 May
TI  - Effects of Elamipretide on Left Ventricular Function in Patients With Heart 
      Failure With Reduced Ejection Fraction: The PROGRESS-HF Phase 2 Trial.
PG  - 429-437
LID - S1071-9164(19)31583-0 [pii]
LID - 10.1016/j.cardfail.2020.02.001 [doi]
AB  - BACKGROUND: Elamipretide, a novel mitochondrial modulating agent, improves 
      myocardial energetics; however, it is unknown whether this mechanistic benefit 
      translates into improved cardiac structure and function in heart failure (HF) 
      with reduced ejection fraction (HFrEF). The objective of this study was to 
      evaluate the effects of multiple subcutaneous doses of elamipretide on left 
      ventricular end systolic volume (LVESV) as assessed by cardiac magnetic resonance 
      imaging. METHODS: We randomized 71 patients with HFrEF (LVEF </= 40%) in a 
      double-blind, placebo-controlled trial in a 1:1:1 ratio to receive placebo, 4 mg 
      or 40 mg elamipretide once daily for 28 consecutive days. RESULTS: The mean age 
      (standard deviation) of the study population was 65 +/- 10 years, 24% were females, 
      and the mean EF was 31% +/- 7%. The change in LVESV from baseline to week 4 was not 
      significantly different between elamipretide 4 mg (89.4 mL to 85 mL; difference, 
      -4.4 mL) or 40 mg (77.9 mL to 76.6 mL; difference, -1.2 mL) compared with placebo 
      (77.7 mL to 74.6 mL; difference, -3.8 mL) (4 mg vs placebo: difference of means, 
      -0.3; 95% CI, -4.6 to 4.0; P  =  0.90; and 40 mg vs placebo: difference of means, 
      2.3; 95% CI, -1.9 to 6.5; P  =  0.28). Also, no significant differences in change 
      in LVESV and LVEF were observed between placebo and either of the elamipretide 
      groups. Rates of any study drug-related adverse events were similar in the 3 
      groups. CONCLUSIONS: Elamipretide was well tolerated but did not improve LVESV at 
      4 weeks in patients with stable HFrEF compared with placebo.
CI  - Copyright (c) 2020. Published by Elsevier Inc.
FAU - Butler, Javed
AU  - Butler J
AD  - Department of Medicine, University of Mississippi Medical Center, Jackson, 
      Missisippi, USA.
FAU - Khan, Muhammad Shahzeb
AU  - Khan MS
AD  - Department of Medicine, Cook County Hospital, Chicago, Illinois, USA.
FAU - Anker, Stefan D
AU  - Anker SD
AD  - Department of Cardiology (CVK), Berlin Institute of Health Center for 
      Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) 
      partner site Berlin, Charite Universitatsmedizin Berlin, Germany.
FAU - Fonarow, Gregg C
AU  - Fonarow GC
AD  - Division of Cardiology, Department of Medicine, University of California, Los 
      Angeles, Los Angeles, California, USA.
FAU - Kim, Raymond J
AU  - Kim RJ
AD  - Duke Cardiovascular Magnetic Resonance Center, Department of Medicine, Duke 
      University School of Medicine, Durham, North Carolina, USA.
FAU - Nodari, Savina
AU  - Nodari S
AD  - Cardiology Section, Department of Clinical and Surgical Specialties, Radiological 
      Sciences and Public Health, University of Brescia, Brescia, Italy.
FAU - O'Connor, Christopher M
AU  - O'Connor CM
AD  - Inova Heart and Vascular Institute, Falls Church, Virginia, USA.
FAU - Pieske, Burkert
AU  - Pieske B
AD  - Department of Internal Medicine and Cardiology, Charite Universitatsmedizin 
      Berlin, Campus Virchow Klinikum, Berlin, Germany; Department of Internal Medicine 
      and Cardiology, German Heart Center Berlin, and German Centre for Cardiovascular 
      Research (DZHK), Partner site Berlin, and Berlin Institute of Health (BIH), 
      Berlin, Germany.
FAU - Pieske-Kraigher, Elisabeth
AU  - Pieske-Kraigher E
AD  - Department of Internal Medicine and Cardiology, Charite Universitatsmedizin 
      Berlin, Campus Virchow Klinikum, Berlin, Germany; Department of Internal Medicine 
      and Cardiology, German Heart Center Berlin, and German Centre for Cardiovascular 
      Research (DZHK), Partner site Berlin, and Berlin Institute of Health (BIH), 
      Berlin, Germany.
FAU - Sabbah, Hani N
AU  - Sabbah HN
AD  - Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan, USA.
FAU - Senni, Michele
AU  - Senni M
AD  - Cardiovascular Department, ASST Papa Giovanni XXIII, Bergamo, Italy.
FAU - Voors, Adriaan A
AU  - Voors AA
AD  - Department of Cardiology, University of Groningen, University Medical Center 
      Groningen, Groningen, the Netherlands.
FAU - Udelson, James E
AU  - Udelson JE
AD  - Division of Cardiology and the Cardiovascular Center, Tufts Medical Center, 
      Boston, Massachusetts, USA.
FAU - Carr, Jim
AU  - Carr J
AD  - Stealth BioTherapeutics, Newton, Massachusetts, USA.
FAU - Gheorghiade, Mihai
AU  - Gheorghiade M
AD  - Department of Medicine, Bluhm Cardiovascular Institute, Northwestern University 
      Feingerg School of Medicine, Chicago, Illinois, USA.
FAU - Filippatos, Gerasimos
AU  - Filippatos G
AD  - National and Kapodistrian University of Athens, Attikon University Hospital, 
      Athens, Greece. Electronic address: geros@otenet.gr.
LA  - eng
GR  - U54 GM115428/GM/NIGMS NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200214
PL  - United States
TA  - J Card Fail
JT  - Journal of cardiac failure
JID - 9442138
RN  - 0 (Oligopeptides)
RN  - 0 (arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide)
SB  - IM
MH  - Aged
MH  - Female
MH  - *Heart Failure/drug therapy
MH  - Humans
MH  - Middle Aged
MH  - Oligopeptides
MH  - Stroke Volume
MH  - *Ventricular Function, Left
OTO - NOTNLM
OT  - Mitochondria
OT  - cardiac MRI
OT  - elamipretide
OT  - heart failure
EDAT- 2020/02/19 06:00
MHDA- 2021/08/19 06:00
CRDT- 2020/02/19 06:00
PHST- 2019/10/01 00:00 [received]
PHST- 2020/02/05 00:00 [revised]
PHST- 2020/02/10 00:00 [accepted]
PHST- 2020/02/19 06:00 [pubmed]
PHST- 2021/08/19 06:00 [medline]
PHST- 2020/02/19 06:00 [entrez]
AID - S1071-9164(19)31583-0 [pii]
AID - 10.1016/j.cardfail.2020.02.001 [doi]
PST - ppublish
SO  - J Card Fail. 2020 May;26(5):429-437. doi: 10.1016/j.cardfail.2020.02.001. Epub 
      2020 Feb 14.