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NCT02814097·Phase 2·INTERVENTIONAL

A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction

Status

Completed

Phase

Phase 2

Enrollment

46

Locations

9

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4 weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function.

Interventions

Treatment arms and agents.

DRUG

elamipretide

Subcutaneous injection of 40 mg elamipretide once daily for 28 consecutive days

DRUG

Placebo

Subcutaneous injection of placebo administered once daily for 28 consecutive days

Timeline

From registration to results.

  1. First posted

    Jun 27, 2016

  2. Study start

    Sep 2, 2016

  3. Primary completion

    May 4, 2017

  4. Study completion

    Jun 2, 2017

  5. Results posted

    Not reported

  6. Registry updated

    Sep 7, 2017

Outcomes

What the study measures.

Primary outcomes

Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups

Time frame · 4 weeks

Secondary outcomes

Compare the change at rest and during submaximal stress in LV systolic global longitudinal strain (GLS) between the elamipretide and placebo groups at the end of the 4-week treatment period

Time frame · 4 weeks

Compare the change in 6-minute walking distance, between the elamipretide and placebo groups at the end of the 4-week treatment period

Time frame · 4 weeks

Compare the change in NT-proBNP, between the elamipretide and placebo groups at the end of the 4-week treatment period

Time frame · 4 weeks

Compare the percent of patients on elamipretide versus placebo presenting with TEAEs and SAEs, including changes in biomarkers of myocardial damage and changes in markers of renal function

Time frame · 4 weeks

Eligibility

Who can take part.

Minimum age
40 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Age ≥45 and \<80 years. * Symptomatic heart failure (i.e. NYHA II or III) due to HFpEF for at least 6 months prior to study start * Evidence of HFpEF: LVEF ≥45% and E/e´\>10 and NT-pro-BNP \>220 pg/ml (sinus rhythm) / \> 600 pg/mL (atrial fibrillation) * An exercise-induced increase in E/e' of at least 1.5 units during stress echocardiography assessment. * Heart failure is considered to be stable, in the judgment of the investigator, and no hospitalization for HFpEF or changes in dose regimen of pharmacologic treatment for HF has occurred within 1 month prior to the Screening Visit. * Treatment with appropriate pharmacologic therapy to manage underlying risk factors according to current guidelines. * Women of childbearing potential must agree to use 1 of the following methods of birth control from the date they sign the ICF until two months after the last dose of study medication: a) Abstinence, b) surgically sterilized male partner, or c) barrier method And hormonal contraception * Women of child-bearing potential must have a negative serum pregnancy test at baseline * Willing and able to provide signed informed consent form (ICF) prior to participation in any study-related procedures Exclusion Criteria: * Probable alternative diagnoses that in the opinion of the investigator could account for the patient's symptoms e.g. severe pulmonary dysfunction or severe asthma * LVEF \<45% (at the moment of enrollment or in medical history) * Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit. * Acute coronary syndrome (ACS), stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit. * Uncontrolled hypertension defined as a systolic blood pressure (BP) \>160 mm Hg or a diastolic BP \>100 mm Hg on at least 2 consecutive readings that will require a change in anti-hypertensive treatment during the study period. * Active cancer or undergoing chemotherapy within previous 6 months * Total bilirubin \>2x the upper limit of normal (ULN) in the absence of Gilbert's Syndrome (M. Meulengracht) and liver enzymes (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] and/or alkaline phosphatase) elevation \>3xULN * Estimated glomerular filtration rate \<30 mL/min, by MDRD * Known active drug or alcohol abuse within 1 year of the Screening Visit. * Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment * Treatment with spironolactone or eplerenone for less than 3 months at study start * Treatment with dabigatran * Treatment with valsartan/sacubitril * Female subjects who are pregnant, planning to become pregnant, or lactating.

Study locations

9 registered sites.

Germany · Serbia. Showing up to 24 locations stored in the fast local snapshot.

Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum

Berlin, Germany

German Heart Center

Berlin, Germany

Clinical Centre of Serbia, Clinic for Cardiology

Belgrade, Serbia

Clinical Hospital Center "Dr Dragiša Mišović-Dedinje", Department of Cardiology

Belgrade, Serbia

Clinical Hospital Center "Zvezdara", Department of Cardiology

Belgrade, Serbia

Clinical Hospital Center "Bežanijska Kosa", Department of Cardiology

Belgrade, Serbia

Clinical Hospital Center "Zemun", Department of Cardiology

Belgrade, Serbia

Institute for Cardiovascular Diseases Vojvodina, Clinic for Cardiology

Kamenitz, Serbia

Clinical Center Niš, Clinic for Cardiology

Niš, Serbia

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.