Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667

Phase 2TerminatedNCT00559650

Bayer150 enrolled

Overview

The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Congestive Heart Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with decompensated chronic congestive heart failure, NYHA functional class III-IV, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling Swan-Ganz pulmonary artery catheter) and PCWP \>/= 18 mmHg. * Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment. * Male or female patients, age 18 years or more. Exclusion Criteria: * Females of child-bearing potential. * Acute de-novo heart failure. * Acute myocardial infarction and/or myocardial infarction within 30 days. * Valvular heart disease requiring surgical intervention during the course of the study.

Locations (72)

Unnamed facility

San Diego, California, United States

Unnamed facility

Washington D.C., District of Columbia, United States

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Cincinnati, Ohio, United States

Unnamed facility

Fairfield, Ohio, United States

Unnamed facility

Outcomes

Primary Outcomes

The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo.

Time frame: 8 hours

Secondary Outcomes

Quality of Life

Time frame: Up to 30 days Follow-up

Rehospitalization

Time frame: Up to 30 days Follow-up

Other hemodynamic measurements

Right atrial pressure (RAP); mean pulmonary artery pressure (PAP mean); pulmonary artery systolic pressure (PASP); pulmonary artery diastolic pressure (PADP); cardiac output (CO); cardiac index (CI); mean arterial pressure (MAP); pulmonary vascular resistance (PVR); pulmonary vascular resistance index (PVRI); systemic vascular resistance (SVR); and systemic vascular resistance index (SVRI）

Time frame: Up to 48 hours

Safety variables

Treatment-emergent adverse events, laboratory parameters, renal function, in-hospital mortality, length of stay at intensive care unit, and 30-day mortality / morbidity.

Time frame: Up to 30 days follow up

Plasma concentrations

Time frame: During both the titration and maintenance phases were evaluated.