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

Primary Purpose

Congestive Heart Failure

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Cinaciguat (BAY58-2667)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Acute decompensated heart failure, Double blind study,, BAY58-2667, Soluble guanylate cyclase activator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life
Rehospitalization
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）
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.
Plasma concentrations

Full Information

First Posted
November 15, 2007
Last Updated
April 14, 2017
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00559650
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Acute decompensated heart failure, Double blind study,, BAY58-2667, Soluble guanylate cyclase activator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Placebo Comparator
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
Intervention Type
Drug
Intervention Name(s)
Cinaciguat (BAY58-2667)
Intervention Description
Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Quality of Life
Time Frame
Up to 30 days Follow-up
Title
Rehospitalization
Time Frame
Up to 30 days Follow-up
Title
Other hemodynamic measurements
Description
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
Title
Safety variables
Description
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
Title
Plasma concentrations
Time Frame
During both the titration and maintenance phases were evaluated.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8765
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219-2316
Country
United States
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216-7167
Country
United States
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Split
ZIP/Postal Code
21000
Country
Croatia
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
City
Hradec kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Plzen
ZIP/Postal Code
301 00
Country
Czech Republic
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
City
Praha 2
ZIP/Postal Code
12808
Country
Czech Republic
City
Tallin
ZIP/Postal Code
13419
Country
Estonia
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32545
Country
Germany
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66424
Country
Germany
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99089
Country
Germany
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07740
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Budapest
ZIP/Postal Code
H-1096
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Vac
ZIP/Postal Code
2600
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
City
Haifa
ZIP/Postal Code
34362
Country
Israel
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
City
Zefat
ZIP/Postal Code
1311001
Country
Israel
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44100
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
City
Moscow
ZIP/Postal Code
109263
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129010
Country
Russian Federation
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
City
Celje
ZIP/Postal Code
3000
Country
Slovenia
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
City
Murska Sobota
ZIP/Postal Code
9000
Country
Slovenia
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
S44 5BL
Country
United Kingdom
City
Barnet
State/Province
Hertfordshire
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22778174
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.
Results Reference
result
Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here and search for Bayer product information provided by EMA

Learn more about this trial

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

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