Clinical trial NCT00559650: Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Congestive Heart Failure
Keywords: Acute decompensated heart failure
Double blind study,
BAY58-2667
Soluble guanylate cyclase activator
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo.
timeFrame: 8 hours
Secondary outcomes:
measure: Quality of Life
timeFrame: Up to 30 days Follow-up
measure: Rehospitalization
timeFrame: Up to 30 days Follow-up
measure: Other hemodynamic measurements
timeFrame: Up to 48 hours
measure: Safety variables
timeFrame: Up to 30 days follow up
measure: Plasma concentrations
timeFrame: During both the titration and maintenance phases were evaluated.
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Boston
country: United States
state: Massachusetts
city: Cincinnati
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Dallas
country: United States
state: Texas
city: Halifax
country: Canada
state: Nova Scotia
city: Toronto
country: Canada
state: Ontario
city: Ste-Foy
country: Canada
state: Quebec
city: Split
country: Croatia
city: Zagreb
country: Croatia
city: Brno
country: Czech Republic
city: Brno
country: Czech Republic
city: Hradec kralove
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Tallin
country: Estonia
city: Tartu
country: Estonia
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Würzburg
country: Germany
state: Bayern
city: Bad Nauheim
country: Germany
state: Hessen
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Bad Oeynhausen
country: Germany
state: Nordrhein-Westfalen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Homburg
country: Germany
state: Saarland
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Erfurt
country: Germany
state: Thüringen
city: Jena
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Vac
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Ramat Gan
country: Israel
city: Zefat
country: Israel
city: Bologna
country: Italy
state: Emilia-Romagna
city: Ferrara
country: Italy
state: Emilia-Romagna
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Perugia
country: Italy
state: Umbria
city: Bergamo
country: Italy
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Szczecin
country: Poland
city: Wroclaw
country: Poland
city: Zabrze
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Beograd
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Celje
country: Slovenia
city: Golnik
country: Slovenia
city: Ljubljana
country: Slovenia
city: Murska Sobota
country: Slovenia
city: Santiago de Compostela
country: Spain
state: A Coruña
city: Sabadell
country: Spain
state: Barcelona
city: Majadahonda
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Girona
country: Spain
city: Göteborg
country: Sweden
city: Uppsala
country: Sweden
city: Chesterfield
country: United Kingdom
state: Derbyshire
city: Barnet
country: United Kingdom
state: Hertfordshire
city: Harrow
country: United Kingdom
state: Middlesex
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Erdmann E, Semigran MJ, Nieminen MS, Gheorghiade M, Agrawal R, Mitrovic V, Mebazaa A. Cinaciguat, a soluble guanylate cyclase activator, unloads the heart but also causes hypotension in acute decompensated heart failure. Eur Heart J. 2013 Jan;34(1):57-67. doi: 10.1093/eurheartj/ehs196. Epub 2012 Jul 9.