Clinical trial NCT01187836: Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure
Official title: A Randomized, Double-Blind, Placebo-Controlled, Adaptive, Ascending Dose-Titration Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Invasive Hemodynamics of TRV120027 in Patients With Stable Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-24
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 range of TRV120027 doses to use in future research studies involving patients with acute decompensated heart failure.


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 \</= 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.

Primary outcomes:
measure: Pulmonary Capillary Wedge Pressure (PCWP)
timeFrame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion
measure: Safety and Tolerability
timeFrame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7, Day 30)
Secondary outcomes:
measure: Pharmacokinetics of TRV120027
timeFrame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion
measure: Additional Hemodynamics
timeFrame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion
measure: Laboratory Evaluations
timeFrame: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7)
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Brno
country: Czechia
facility: CZ05
city: Olomouc
country: Czechia
facility: CZ04
city: Prague
country: Czechia
facility: CZ06
city: Warsaw
country: Poland
facility: PL01
city: Wroclaw
country: Poland
facility: PL05
Study officials:
affiliation: Trevena Inc.
name: David G Soergel, M.D.
role: STUDY_DIRECTOR
References: