Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure

Trevena Inc.33 enrolled

Overview

In this study, TRV120027 (or a placebo) intravenous infusion will be given to people with heart failure to learn about the effects of TRV120027. The results of this study will help choose the proper range of TRV120027 doses to use in future research studies involving patients with acute decompensated heart failure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Heart Failure

Interventions

TRV120027DRUG

Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours.

PlaceboDRUG

Placebo administered for 14 hours.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of congestive heart failure made at least 3 months prior to screening * NYHA Class III or IV heart failure, ejection fraction \</= 35% and , and in the opinion of the investigator, right-heart catheterization is clinically indicated. * Baseline mean PCWP \>/= 20 mmHg * Systolic blood pressure at screening must be \>/= 100 mmHg. Heart rate at screening must be \</= 90 bpm. Exclusion Criteria: * Any significant disease or condition that would interfere with the interpretation of safety or efficacy in this study as determined by the Investigator based on medical history, physical examination or laboratory tests. * Significant valve disease * Current signs or symptoms of acute myocardial ischemia or acute coronary syndrome (ACS) or coronary revascularization in the past 3 months. * Sustained or uncontrolled ventricular arrhythmia. Inclusion of patients with atrial fibrillation with a heart rate ≤ 90 bpm is permitted.

Locations (9)

Unnamed facility

Miami, Florida, United States

University of Maryland

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Pulmonary Capillary Wedge Pressure (PCWP)

The effect of TRV120027 on pulmonary capillary wedge pressure will be compared to baseline and to placebo at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion.

Time frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion

Safety and Tolerability

Safety and tolerability will be assessed qualitatively by evaluating adverse events, clinical laboratories, ECGs, cardiac telemetry and vital signs at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion. Follow-up assessments for adverse events at Day 7 and Day 30 will be conducted.

Time frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7, Day 30)

Secondary Outcomes

Pharmacokinetics of TRV120027

PK samples will be collected at multiple time points during the 14 hour infusion and 4 hour washout periods.

Time frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion

Additional Hemodynamics

Additional hemodynamic variables (for example, right atrial pressure, pulmonary arterial pressure and cardiac output) will be compared to baseline and to placebo at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion.

Time frame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion

Laboratory Evaluations

Biomarkers of renal function and neurohormonal activation will be assessed at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion, and again at follow-up Day 7.

Data from ClinicalTrials.gov

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