Trial | NCT01187836  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    trv120027 ...

  • Study Participants

    33
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.
Study Started
Dec 31
2010
Primary Completion
Mar 31
2012
Study Completion
Mar 31
2012
Last Update
Jul 11
2017

Drug TRV120027

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

Drug Placebo

Placebo administered for 14 hours.

TRV120027 Experimental

Placebo Placebo Comparator

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.
No Results Posted