Status:
COMPLETED
Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure
Lead Sponsor:
Trevena Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
PHASE2
Brief 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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01187836
Start Date
December 1 2010
End Date
March 1 2012
Last Update
July 11 2017
Active Locations (9)
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1
Miami, Florida, United States, 33136
2
University of Maryland
Baltimore, Maryland, United States, 21201
3
Tufts Medical Center
Boston, Massachusetts, United States, 02111
4
University of Utah
Salt Lake City, Utah, United States, 84132