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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01187836

Run by

Trevena Inc.

People needed

33

Starts

2010-12-01

Expected to finish

2012-03-01

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — 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
• CZ05 — Brno, Czechia
• CZ04 — Olomouc, Czechia
• CZ06 — Prague, Czechia
• PL01 — Warsaw, Poland
• PL05 — Wroclaw, Poland

Full record on ClinicalTrials.gov

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