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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT00559650

Run by

Bayer

People needed

150

Starts

2007-12-01

Expected to finish

2009-03-01

Last updated by the study team

2017-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Washington D.C., District of Columbia, United States
• Study site — Boston, Massachusetts, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Fairfield, Ohio, United States
• Study site — Dallas, Texas, United States
• Study site — Halifax, Nova Scotia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Ste-Foy, Quebec, Canada
• Study site — Split, Croatia
• Study site — Zagreb, Croatia
• Study site — Brno, Czechia
• Study site — Brno, Czechia
• Study site — Hradec Králové, Czechia
• Study site — Pilsen, Czechia
• Study site — Prague, Czechia
• Study site — Prague, Czechia
• Study site — Tallinn, Estonia
• Study site — Tartu, Estonia
• Study site — Heidelberg, Baden-Wurttemberg, Germany
• Study site — Würzburg, Bavaria, Germany
• Study site — Bad Nauheim, Hesse, Germany
• Study site — Greifswald, Mecklenburg-Vorpommern, Germany
• Study site — Bad Oeynhausen, North Rhine-Westphalia, Germany
• Study site — Bonn, North Rhine-Westphalia, Germany
• Study site — San Diego, California, United States

Full record on ClinicalTrials.gov

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