Heart Failure Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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 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.

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

33

Study ID:

NCT01187836

Recruitment Status:

Completed

Sponsor:

Trevena Inc.

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There are 9 Locations for this study

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Miami Florida, 33136, United States
University of Maryland
Baltimore Maryland, 21201, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
University of Utah
Salt Lake City Utah, 84132, United States
CZ05
Brno , 656 9, Czechia
CZ04
Olomouc , 779 0, Czechia
CZ06
Prague , 150 3, Czechia
PL01
Warsaw , 04-62, Poland
PL05
Wroclaw , 50-98, Poland

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

33

Study ID:

NCT01187836

Recruitment Status:

Completed

Sponsor:


Trevena Inc.

How clear is this clinincal trial information?

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