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

Stealth BioTherapeutics

Status and phase

Completed

Phase 2

Conditions

Chronic Heart Failure

Treatments

Drug: Placebo

Drug: elamipretide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02814097

SPIHF-203

2015-005615-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.