Evidence map›Paper›PMID 29217757›Full record

Trial reportCirculation. Heart failure2017

Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide.

Melissa A Daubert, Eric Yow, Gary Dunn, Sotir Marchev, Huiman Barnhart, Pamela S Douglas, Christopher O'Connor, Sidney Goldstein, James E Udelson, Hani N Sabbah

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Circulation. Heart failure, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02388464 (A Phase 1 Clinical Pharmacology Study of the Effects of a Single 4 Hour Intravenous Infusion of Bendavia™), which is not on this map. Cited by 113 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
113citing papers in PubMed, 2 pooled it
12.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02388464 phase1completednot on this map

A Phase 1 Clinical Pharmacology Study of the Effects of a Single 4 Hour Intravenous Infusion of Bendavia™ (MTP-131) in Subjects With Stable New York Heart Association Class II-III Congestive Heart Failure Due to Left Ventricular Systolic Dysfunction

TypeinterventionalSponsorStealth BioTherapeutics Inc.Ran2014 to 2015Enrolled36ConditionsCongestive Heart FailureArmsMTP-131, Placebo
3 · Its place in the literature

Who cites it

113 citing papers in PubMed, 2 syntheses or guidelines pooled it, 176 citations in OpenAlex.

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53 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 2 countries.

Melissa A DaubertFrom the Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.A.D., E.Y., G.D., H.B., P.S.D.); Medical University of Pleven, Bulgaria (S.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.O.); Henry Ford Hospital, Detroit, MI (S.G., H.N.S.); and Tufts Medical Center, Boston, MA (J.E.U.). melissa.daubert@duke.edu.
Eric YowFrom the Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.A.D., E.Y., G.D., H.B., P.S.D.); Medical University of Pleven, Bulgaria (S.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.O.); Henry Ford Hospital, Detroit, MI (S.G., H.N.S.); and Tufts Medical Center, Boston, MA (J.E.U.).
Gary DunnFrom the Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.A.D., E.Y., G.D., H.B., P.S.D.); Medical University of Pleven, Bulgaria (S.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.O.); Henry Ford Hospital, Detroit, MI (S.G., H.N.S.); and Tufts Medical Center, Boston, MA (J.E.U.).
Sotir MarchevFrom the Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.A.D., E.Y., G.D., H.B., P.S.D.); Medical University of Pleven, Bulgaria (S.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.O.); Henry Ford Hospital, Detroit, MI (S.G., H.N.S.); and Tufts Medical Center, Boston, MA (J.E.U.).
Huiman BarnhartFrom the Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.A.D., E.Y., G.D., H.B., P.S.D.); Medical University of Pleven, Bulgaria (S.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.O.); Henry Ford Hospital, Detroit, MI (S.G., H.N.S.); and Tufts Medical Center, Boston, MA (J.E.U.).
Pamela S DouglasFrom the Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.A.D., E.Y., G.D., H.B., P.S.D.); Medical University of Pleven, Bulgaria (S.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.O.); Henry Ford Hospital, Detroit, MI (S.G., H.N.S.); and Tufts Medical Center, Boston, MA (J.E.U.).
Christopher O'ConnorFrom the Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.A.D., E.Y., G.D., H.B., P.S.D.); Medical University of Pleven, Bulgaria (S.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.O.); Henry Ford Hospital, Detroit, MI (S.G., H.N.S.); and Tufts Medical Center, Boston, MA (J.E.U.).
Sidney GoldsteinFrom the Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.A.D., E.Y., G.D., H.B., P.S.D.); Medical University of Pleven, Bulgaria (S.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.O.); Henry Ford Hospital, Detroit, MI (S.G., H.N.S.); and Tufts Medical Center, Boston, MA (J.E.U.).
James E UdelsonFrom the Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.A.D., E.Y., G.D., H.B., P.S.D.); Medical University of Pleven, Bulgaria (S.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.O.); Henry Ford Hospital, Detroit, MI (S.G., H.N.S.); and Tufts Medical Center, Boston, MA (J.E.U.).
Hani N SabbahFrom the Duke University Medical Center, Duke Clinical Research Institute, Durham, NC (M.A.D., E.Y., G.D., H.B., P.S.D.); Medical University of Pleven, Bulgaria (S.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.O.); Henry Ford Hospital, Detroit, MI (S.G., H.N.S.); and Tufts Medical Center, Boston, MA (J.E.U.).
Alaska Heart and Vascular Institute · USMedical University Pleven · BGHenry Ford Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMitochondrial dysfunction and energy depletion in the failing heart are innovative therapeutic targets in heart failure management. Elamipretide is a novel tetrapeptide that increases mitochondrial energy; however, its safety, tolerability, and therapeutic effect on cardiac structure and function have not been studied in heart failure with reduced ejection fraction. METHODS AND

resultsIn this double-blind, placebo-controlled, ascending-dose trial, patients with heart failure with reduced ejection fraction (ejection fraction, ≤35%) were randomized to either a single 4-hour infusion of elamipretide (cohort 1 [n=8], 0.005; cohort 2 [n=8], 0.05; and cohort 3 [n=8], 0.25 mg·kg

conclusionsThis is the first study to evaluate elamipretide in heart failure with reduced ejection fraction and demonstrates that a single infusion of elamipretide is safe and well tolerated. High-dose elamipretide resulted in favorable changes in left ventricular volumes that correlated with peak plasma concentrations, supporting a temporal association and dose-effect relationship. Further study of elamipretide is needed to determine long-term safety and efficacy. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT02388464.

Indexed as

AgedBulgariaCardiovascular AgentsDouble-Blind MethodEchocardiographyEnergy MetabolismFemaleHeart FailureHumansInfusions, IntravenousMaleMiddle AgedMitochondria, HeartOligopeptidesProspective StudiesStroke Volumearginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamideCardiovascular AgentsOligopeptidesblood pressureheart failureheart ratehumansstroke volume

Identifiers

PMID29217757
OpenAlexW2773343324

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.