NCT02914665

A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure

Completed Phase 2 Last updated 28 July 2020

What this trial tests

Phase 2 trial testing elamipretide in Heart Failure in 308 participants. Completed in 27 November 2017.

Timeline

20 October 2016

Primary endpoint
27 November 2017

27 November 2017

Quick facts

Lead sponsor	Stealth BioTherapeutics Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	308
Start date	20 October 2016
Primary completion	27 November 2017
Estimated completion	27 November 2017
Sites	46 locations across France, Netherlands, Belgium, Serbia, United Kingdom, Hungary, Poland, Bulgaria

Drugs / interventions tested

• elamipretide (ELAMIPRETIDE) — full drug profile →
• Placebo

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Stealth BioTherapeutics Inc. — full company profile →

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac and renal effects of short term treatment with elamipretide in patients hospitalized with congestion due to heart failure

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of Oxidative Stress on the Heart and Vasculature: Part 2 of a 3-Part Series.
   Münzel T, Camici GG, Maack C, Bonetti NR, et al · · 2017 · cited 427× · PMID 28683969 · DOI 10.1016/j.jacc.2017.05.035
2. Sources of Vascular Nitric Oxide and Reactive Oxygen Species and Their Regulation
   Tejero J, Shiva S, Gladwin MT. · · 2019 · cited 357× · PMID 30379623 · DOI 10.1152/physrev.00036.2017
3. Targeting mitochondria for cardiovascular disorders: therapeutic potential and obstacles.
   Bonora M, Wieckowski MR, Sinclair DA, Kroemer G, et al · · 2019 · cited 226× · PMID 30177752 · DOI 10.1038/s41569-018-0074-0
4. Mitochondrial ROS Drive Sudden Cardiac Death and Chronic Proteome Remodeling in Heart Failure.
   Dey S, DeMazumder D, Sidor A, Foster DB, et al · · 2018 · cited 205× · PMID 29898892 · DOI 10.1161/circresaha.118.312708
5. Oxidative Stress and New Pathogenetic Mechanisms in Endothelial Dysfunction: Potential Diagnostic Biomarkers and Therapeutic Targets.
   Scioli MG, Storti G, D'Amico F, Rodríguez Guzmán R, et al · · 2020 · cited 178× · PMID 32630452 · DOI 10.3390/jcm9061995
6. Targeting mitochondrial dysfunction and oxidative stress in heart failure: Challenges and opportunities.
   Kiyuna LA, Albuquerque RPE, Chen CH, Mochly-Rosen D, et al · · 2018 · cited 160× · PMID 30227272 · DOI 10.1016/j.freeradbiomed.2018.09.019
7. Therapeutic approaches in heart failure with preserved ejection fraction: past, present, and future.
   Wintrich J, Kindermann I, Ukena C, Selejan S, et al · · 2020 · cited 76× · PMID 32236720 · DOI 10.1007/s00392-020-01633-w
8. Tubular Mitochondrial Dysfunction, Oxidative Stress, and Progression of Chronic Kidney Disease.
   Fontecha-Barriuso M, Lopez-Diaz AM, Guerrero-Mauvecin J, Miguel V, et al · · 2022 · cited 70× · PMID 35883847 · DOI 10.3390/antiox11071356