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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TRV120027

Group Type EXPERIMENTAL

TRV120027

Intervention Type DRUG

Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered for 14 hours.

Interventions

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TRV120027

Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours.

Intervention Type DRUG

Placebo

Placebo administered for 14 hours.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No