Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2007 |
| End Date: | March 2009 |
Placebo Controlled, Randomized, Double-blind, Multi-center, Multinational Phase IIb Study to Investigate the Efficacy and Tolerability of BAY58-2667 Given Intravenously in Patients With Decompensated Chronic Congestive Heart Failure
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.
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.
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.
We found this trial at
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