NCT02814097

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 2, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2017

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

June 8, 2016

Last Update Submit

September 6, 2017

Conditions

Chronic Heart Failure

Keywords

Heart FailureHFpEFelamipretideMTP-131Bendavia™

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (4)

  • 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

    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

    4 weeks

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

    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

    4 weeks

Study Arms (2)

40 mg elamipretide

EXPERIMENTAL

40 mg elamipretide once daily for 28 consecutive days

Drug: elamipretide

Placebo

PLACEBO COMPARATOR

Placebo once daily for 28 consecutive days

Drug: Placebo

Interventions

elamipretideDRUG

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

Also known as: MTP-131, Bendavia
40 mg elamipretide
PlaceboDRUG

Subcutaneous injection of placebo administered once daily for 28 consecutive days

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

German Heart Center

Berlin, 13353, Germany

Location

Clinical Centre of Serbia, Clinic for Cardiology

Belgrade, 11000, Serbia

Location

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

Belgrade, 11000, Serbia

Location

Clinical Hospital Center "Zvezdara", Department of Cardiology

Belgrade, 11000, Serbia

Location

Clinical Hospital Center "Bežanijska Kosa", Department of Cardiology

Belgrade, 11080, Serbia

Location

Clinical Hospital Center "Zemun", Department of Cardiology

Belgrade, 11080, Serbia

Location

Institute for Cardiovascular Diseases Vojvodina, Clinic for Cardiology

Kamenitz, 21204, Serbia

Location

Clinical Center Niš, Clinic for Cardiology

Niš, 18000, Serbia

Location

MeSH Terms

Conditions

Heart Failure

Interventions

arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 27, 2016

Study Start

September 2, 2016

Primary Completion

May 4, 2017

Study Completion

June 2, 2017

Last Updated

September 7, 2017

Record last verified: 2017-09

Locations

SE(7)DE(2)