Overview

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

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Trevena Inc.
Criteria
Inclusion Criteria:

- Diagnosis of congestive heart failure made at least 3 months prior to screening

- NYHA Class III or IV heart failure, ejection fraction 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
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.