Current partner codePEPTIDESDE
NCT02914665·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

308

Locations

46

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

elamipretide

20 mg elamipretide administered intravenously once daily for 7 consecutive days

DRUG

Placebo

Placebo administered intravenously once daily for 7 consecutive days

Timeline

From registration to results.

  1. First posted

    Sep 26, 2016

  2. Study start

    Oct 20, 2016

  3. Primary completion

    Nov 27, 2017

  4. Study completion

    Nov 27, 2017

  5. Results posted

    Not reported

  6. Registry updated

    Jul 28, 2020

Outcomes

What the study measures.

Primary outcomes

Change in NT-proBNP between Baseline and Day 8/Early Discharge

Time frame · Baseline to Day 8

Secondary outcomes

Number of patients staying in the same functional renal function class measured with MDRD formula compared to the number of patients with decreasing or increasing renal function measured with MDRD formula

Time frame · Baseline to Day 3 and Day 8

Number of patients showing a decrease in body weight compared to baseline as well as number of patients showing either no decrease or an increase in body weight compared to baseline

Time frame · Baseline to Day 3 and Day 8

Calculation of decrease or increase in body weight normalised to the average dose (in mg) of furosemide administered

Time frame · Baseline to Day 3 and Day 8

The patient and physician global assessment is a 7-point scale which either the patient or the physician will assess from 0 to 10 and will be mathematically averaged on a daily basis in order to compare the different averages throughout the study.

Time frame · Baseline to Day 3 and Day 8

The average daily dose of diuretic (furosemide - adjusted for thiazide dose if administered) between baseline and Day 3 and Day 8/Early Discharge

Time frame · Baseline to Day 3 and Day 8

All adverse events, serious adverse events and SUSARs will be summarised per treatment group, namely elamipretide versus placebo, and compared at the end of the study.

Time frame · Baseline to Day 8

Half-life (T1/2)

Time frame · Baseline to Day 8

Area under the concentration - time curve from 0-24 h (AUC 0-24)

Time frame · Baseline to Day 8

Area under the concentration - time curve from 0- infinity (AUC 0-∞)

Time frame · Baseline to Day 8

Peak Plasma Concentration (Cmax)

Time frame · Baseline to Day 8

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * A history of chronic heart failure for at least 1 month * 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: * Acute coronary syndrome, stroke, or transient ischemic attack (TIA), coronary or peripheral revascularization procedures, valve procedures, OR any major surgical procedure within the previous 6 weeks * 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

Study locations

46 registered sites.

Belgium · Bulgaria · France · Hungary · Latvia · Netherlands · Poland · Serbia · Spain · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Elamipretide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.