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

NCT ID: NCT02814097

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-02
• Study Completion Date: 2017-06-02

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

40 mg elamipretide

40 mg elamipretide once daily for 28 consecutive days

Group Type: EXPERIMENTAL

elamipretide

Intervention Type: DRUG

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

Placebo

Placebo once daily for 28 consecutive days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous injection of placebo administered once daily for 28 consecutive days

Interventions

elamipretide

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

Intervention Type: DRUG

Placebo

Subcutaneous injection of placebo administered once daily for 28 consecutive days

Intervention Type: DRUG

Other Intervention Names

MTP-131; Bendavia

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

SCIRENT Clinical Research and Science d.o.o.

UNKNOWN

Sponsor Role: collaborator

Stealth BioTherapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Germany; Serbia

Other Identifiers

2015-005615-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPIHF-203

Identifier Type: -

Identifier Source: org_study_id