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

Sponsor
Bayer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00559650
Collaborator
(none)
150
Enrollment
72
Locations
2
Arms
15
Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: Cinaciguat (BAY58-2667)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Arm 1

Drug: Placebo
Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
Experimental: Arm 2

Drug: Cinaciguat (BAY58-2667)
Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Quality of Life [Up to 30 days Follow-up]

  2. Rehospitalization [Up to 30 days Follow-up]

  3. Other hemodynamic measurements [Up to 48 hours]

    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）

  4. Safety variables [Up to 30 days follow up]

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

  5. Plasma concentrations [During both the titration and maintenance phases were evaluated.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Diego California United States 92103-8765
2 Washington District of Columbia United States 20010
3 Boston Massachusetts United States 02114
4 Cincinnati Ohio United States 45219-2316
5 Fairfield Ohio United States 45014
6 Dallas Texas United States 75216-7167
7 Halifax Nova Scotia Canada B3H 3A7
8 Toronto Ontario Canada M5B 1W8
9 Ste-Foy Quebec Canada G1V 4G5
10 Split Croatia 21000
11 Zagreb Croatia 10000
12 Brno Czech Republic 625 00
13 Brno Czech Republic 656 91
14 Hradec kralove Czech Republic 500 05
15 Plzen Czech Republic 301 00
16 Praha 2 Czech Republic 128 08
17 Praha 2 Czech Republic 12808
18 Tallin Estonia 13419
19 Tartu Estonia 51014
20 Heidelberg Baden-Württemberg Germany 69120
21 Würzburg Bayern Germany 97080
22 Bad Nauheim Hessen Germany 61231
23 Greifswald Mecklenburg-Vorpommern Germany 17475
24 Bad Oeynhausen Nordrhein-Westfalen Germany 32545
25 Bonn Nordrhein-Westfalen Germany 53105
26 Köln Nordrhein-Westfalen Germany 50924
27 Homburg Saarland Germany 66424
28 Halle Sachsen-Anhalt Germany 06120
29 Erfurt Thüringen Germany 99089
30 Jena Thüringen Germany 07740
31 Berlin Germany 12200
32 Budapest Hungary H-1096
33 Debrecen Hungary 4032
34 Vac Hungary 2600
35 Zalaegerszeg Hungary 8900
36 Haifa Israel 34362
37 Jerusalem Israel 9112001
38 Ramat Gan Israel 5262000
39 Zefat Israel 1311001
40 Bologna Emilia-Romagna Italy 40138
41 Ferrara Emilia-Romagna Italy 44100
42 Milano Lombardia Italy 20162
43 Pavia Lombardia Italy 27100
44 Perugia Umbria Italy 06156
45 Bergamo Italy 24128
46 Kaunas Lithuania 50009
47 Vilnius Lithuania 08661
48 Gdansk Poland 80-211
49 Krakow Poland 31-202
50 Szczecin Poland 70-111
51 Wroclaw Poland 50-981
52 Zabrze Poland 41-800
53 Moscow Russian Federation 109263
54 Moscow Russian Federation 115093
55 Moscow Russian Federation 119435
56 Moscow Russian Federation 129010
57 Beograd Serbia 11000
58 Sremska Kamenica Serbia 21204
59 Celje Slovenia 3000
60 Golnik Slovenia 4204
61 Ljubljana Slovenia 1000
62 Murska Sobota Slovenia 9000
63 Santiago de Compostela A Coruña Spain 15706
64 Sabadell Barcelona Spain 08208
65 Majadahonda Madrid Spain 28222
66 Barcelona Spain 08036
67 Girona Spain 17007
68 Göteborg Sweden 413 45
69 Uppsala Sweden 751 85
70 Chesterfield Derbyshire United Kingdom S44 5BL
71 Barnet Hertfordshire United Kingdom EN5 3DJ
72 Harrow Middlesex United Kingdom HA1 3UJ

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00559650
Other Study ID Numbers:
  • 12480
  • 2007-003059-36
First Posted:
Nov 16, 2007
Last Update Posted:
Apr 18, 2017
Last Verified:
Apr 1, 2017
Keywords provided by Bayer
Acute decompensated heart failure
Double blind study,
BAY58-2667
Soluble guanylate cyclase activator
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Apr 18, 2017