NCT02388529
Withdrawn
Phase 1
A Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure Due to Reduced Left Ventricular Ejection Fraction
Overview
- Phase
- Phase 1
- Intervention
- MTP-131
- Conditions
- Heart Failure
- Sponsor
- Stealth BioTherapeutics Inc.
- Primary Endpoint
- Incidence of Adverse Events
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
This study is a single-center, randomized, double-blind, placebo-controlled study in patients with stable heart failure to evaluate the safety, tolerability, pharmacokinetics, and efficacy of multiple ascending doses of Bendavia™ (MTP-131) intravenous infusion.
Investigators
Eligibility Criteria
Inclusion Criteria
- •LVEF ≤45% by 2-D echocardiogram.
- •Diagnosis of New York Heart Association Class II or III HF for a minimum of 6 months prior to the Screening Visit.
- •HF is considered to be stable, in the judgment of the Principal Investigator and no hospitalization related to HF has occurred within the 1 month prior to the Screening Visit.
- •Treatment with appropriate pharmacologic therapy for HF including, but not limited to, angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB), and an evidence-based beta blocker for the treatment of HF
- •Females of child-bearing potential must have a negative serum pregnancy test at the Screening Visit.
- •Written informed consent obtained that strictly adheres to the written guidelines from the local Ethical Committee (EC).
Exclusion Criteria
- •Unstable angina pectoris within 1 month before initiation of screening procedures. Unstable angina is defined as the occurrence of chest pain more frequently than usual, pain at rest or upon minimal exertion, or protracted episodes of pain without any discernible trigger, and/or chest pain that persists despite use of vasodilatory therapy (e.g., nitroglycerin).
- •Coronary or peripheral artery revascularization procedure within 2 months prior to the Screening Visit.
- •An acute myocardial infarction within 3 months prior to the Screening Visit.
- •Supine resting heart rate ≥ 100 beats per minute after 5 minutes rest.
- •Uncontrolled hypertension defined as a systolic blood pressure (BP) \>180 mm Hg or a diastolic BP \>110 mm Hg on at least 2 consecutive readings.
- •Requirement for valve or other cardiac surgery (e.g., pericardectomy).
- •Cardiac surgery or valvuloplasty within 2 month prior to the Screening Visit.
- •General surgery within 1 month prior to the Screening Visit.
- •Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic left ventricular aneurysm.
- •Cerebrovascular accident or transient ischemic attack within 3 months prior to the Screening Visit.
Arms & Interventions
Intermediate dose
Intervention: MTP-131
Low dose
Intervention: MTP-131
High dose
Intervention: MTP-131
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of Adverse Events
Time Frame: Assessed up to Day 33
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
Time Frame: Assessed up to Day 12
Secondary Outcomes
- Changes in echocardiographic LV end-systolic volume (LVESV)(Assessed up to Day 33)
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