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
NCT ID: NCT02914665
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
308 participants
INTERVENTIONAL
2016-10-20
2017-11-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension
NCT03554291
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
NCT00036062
Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
NCT03015402
Effect iNO on Functional Respiratory Imaging in Subjects With WHO Group 3 Pulmonary Hypertension With COPD on Oxygen
NCT03135860
Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH
NCT02725372
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
20 mg elamipretide
20 mg elamipretide once daily for 7 consecutive days
elamipretide
20 mg elamipretide administered intravenously once daily for 7 consecutive days
Placebo
Placebo once daily for 7 consecutive days
Placebo
Placebo administered intravenously once daily for 7 consecutive days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
elamipretide
20 mg elamipretide administered intravenously once daily for 7 consecutive days
Placebo
Placebo administered intravenously once daily for 7 consecutive days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Treated with ≥40 mg/day of furosemide or bumetanide ≥1 mg/day or torasemide ≥10 mg/day for at least 1 month
* In-hospital observation/admission and treatment for ≤72 hours and primary cause for admission is heart failure with persistent congestion in the opinion of the Investigator (i.e. at least +2 pitting oedema and/or an estimated 8 kg gain in weight over baseline over the past 4 weeks) requiring intravenous loop diuretic therapy
* Sufficiently severe oedema to justify treatment by an intravenous infusion of furosemide of 10 mg/hour for at least 48 hours
* Systolic blood pressure \>90 mmHg and considered to be haemodynamically stable, in the opinion of the Investigator
* History of left ventricular ejection fraction (LVEF) ≤40% confirmed in the last 18 months
* NT-proBNP \>1500 pg/ml or BNP \>500 pg/ml
* An eGFR of \>30 mL/min/1.73 m2 using the eGFR (mL/min/1.73 m2) = 175 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African American)
Exclusion Criteria
* Invasive cardiac investigation and/or treatment (i.e. coronary angiography, percutaneous coronary intervention \[PCI\] or surgery) or other surgical procedure planned in the next 4 weeks
* Use of intravenous radiographic contrast agent within 72 hours prior to screening or planned use during the study
* Severe, in the investigators opinion, uncorrected valve disease or congenital heart disease as the cause for cardiac decompensation
* Acute mechanical cause of decompensated heart failure such as papillary muscle rupture
* Obstructive or infiltrative cardiomyopathy (e.g. amyloid, sarcoid, etc), suspected acute myocarditis, or heart failure related to an untreated metabolic condition (e.g. haemochromatosis)
* Second or third degree heart block unless the subject has a ventricular pacemaker
* Atrial fibrillation/flutter with sustained ventricular response of \>130 bpm
* Placement of a ventricular resynchronization device within the previous 6 weeks
* Treatment or planned treatment with intravenous inotropic agents other than digoxin at any time on this admission
* Receipt of intravenous vasodilator therapy ≤ 6 hours prior to randomization
* The presence of any mechanical assist device or listed for or a history of a heart transplant
* Severe respiratory disease or anticipated need for mechanical respiratory support (i.e. mechanical ventilation)
* Anuric in the previous 24 hours
* Haemoglobin \<9 g/dL at screening or planned blood transfusions in the next 30 days
* Serum potassium \>5.5 mEq/L
* Marked proteinuria suggestive of nephrotic syndrome
* Estimated GFR (eGFR) as per MDRD equation \<30 ml/min
* Serum albumin of \< 2.8 g/dL
* Liver enzymes (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) elevation \>5 times the upper limit of normal (ULN)
* Total bilirubin \>2.0 times ULN in the absence of Gilbert's Syndrome
* Current or planned ultrafiltration, paracentesis, haemofiltration or dialysis
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stealth BioTherapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Onze Lieve Vrouw campus Aalst
Aalst, , Belgium
Hospital ZNA Middelheim
Antwerp, , Belgium
Department of Internal Diseases, "Multiprofile Hospital for Active Treatment Sveta Ekaterina - Dimitrovgrad" EOOD
Dimitrovgrad, , Bulgaria
Clinic of Cardiology, "Second Multiprofile Hospital for Active Treatement - Sofia" EAD
Sofia, , Bulgaria
Clinic of Cardiology, Multiprofile Hospital for Active Treatment National Heart Hospital" EAD
Sofia, , Bulgaria
Clinic of Cardiology, "City Clinic University Multiprofile Hospital for Active Treatment" EOOD
Sofia, , Bulgaria
Clinic of Internal Diseases, "Multiprofile Hospital for Active Treatment, "Sveta Anna Sofia" AD
Sofia, , Bulgaria
Department of Cardiology, "Multiprofile Regional Hospital for Active Treatement Dr. Stefan Cherkezov" AD
Veliko Tarnovo, , Bulgaria
Hôpital Henri Mondor
Créteil, , France
CHU de Rangueil
Toulouse, , France
Hungarian Institute Of Cardiology, Department of Adult Cardiology
Budapest, , Hungary
Semmelweis University Heart and Vascular Center
Budapest, , Hungary
County St. George University Teaching Hospital, Department of Internal Medicine Cardiology
Székesfehérvár, , Hungary
Zala County Hospital Cardiology Department
Zalaegerszeg, , Hungary
Daugavpils Regional Hospital
Daugavpils, , Latvia
Riga East Clinical University Hospital, Clinic Gailezers
Liepāja, , Latvia
Liepaja Regional Hospital
Liepāja, , Latvia
Pauls Stradins Clinical University Hospital, Latvian Centre of Cardiology
Riga, , Latvia
Hospital Jeroen Bosch
's-Hertogenbosch, , Netherlands
Deventer Hospital
Deventer, , Netherlands
Hospital Gelderse Vallei
Ede, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Hospital Antonius/D&A research Genetic
Sneek, , Netherlands
Hospital Elisabeth -Tweesteden
Tilburg, , Netherlands
Hospitals Gelre
Zutphen, , Netherlands
Bieganski Provincial Specialist Hospital, Department of Cardiology, Clinic of Cardiology UM
Lodz, , Poland
Cardinal Stefan Wyszynski, Institute of Cardiology, Clinic Heart Failure and Transplantation
Warsaw, , Poland
Cardinal Stefan Wyszynski, Institute of Cardiology, Clinic of Coronary Heart Disease and Structural Heart Disease
Warsaw, , Poland
Clinical Centre of Serbia, Emergency Centre
Belgrade, , Serbia
Clinical Centre of Serbia, Institute for Cardiovascular Diseases
Belgrade, , Serbia
Clinical Hospital Centre Bezanijska kosa
Belgrade, , Serbia
Clinical Hospital Centre Zemun
Belgrade, , Serbia
Institute for Cardiovascular Diseases of Vojvodina
Kamenitz, , Serbia
Clinical Centre Nis
Niš, , Serbia
Complexo Hospitalario Universitario de A Coruña
A Coruña, , Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Hospital Alvaro Cunqueiro
Pontevedra, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Consorci Hospital General Universitari de Valencia
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Bradford Royal Infirmary
Bradford, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Torbay Hospital
Torquay, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-000126-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPIHF-204
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.