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

Trevena

Status and phase

Completed

Phase 2

Phase 1

Conditions

Heart Failure

Treatments

Drug: Placebo

Drug: TRV120027

Study type

Interventional

Funder types

Industry

Identifiers

NCT01187836

CP120027.2001

2010-020376-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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.