stop_circleTerminated/Withdrawn

Congestive Heart Failure

Bayer Identifier:

12480

ClinicalTrials.gov Identifier:

NCT00559650

EudraCT Number:

2007-003059-36

EU CT Number:

Not Available
Placebo controlled, randomized, double-blind, multi-center study to investigate the efficacy and tolerability of BAY58-2667

Trial purpose

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 Participants Requirements

Sex

Both

Age

18 Years
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
150
Trial Dates
December 2007 - March 2009
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Cinaciguat (BAY58-2667)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Halle, 06120, Germany
Completed
Erfurt, 99089, Germany
Terminated
Bad Oeynhausen, 32545, Germany
Terminated
Harrow, HA1 3UJ, United Kingdom
Terminated
Chesterfield, S44 5BL, United Kingdom
Terminated
Washington, 20010, United States
Terminated
Krakow, 31-202, Poland
Completed
Wroclaw, 50-981, Poland
Completed
Pavia, 27100, Italy
Terminated
Perugia, 06156, Italy
Completed
Ferrara, 44100, Italy
Completed
Bologna, 40138, Italy
Completed
Bergamo, 24128, Italy
Terminated
Milano, 20162, Italy
Terminated
Santiago de Compostela, 15706, Spain
Completed
Köln, 50924, Germany
Completed
Bad Nauheim, 61231, Germany
Completed
Homburg, 66424, Germany
Terminated
Heidelberg, 69120, Germany
Completed
Bonn, 53105, Germany
Terminated
Würzburg, 97080, Germany
Completed
Greifswald, 17475, Germany
Completed
Jena, 07740, Germany
Terminated
Berlin, 12200, Germany
Terminated
Barnet, EN5 3DJ, United Kingdom
Terminated
Cincinnati, 45219-2316, United States
Completed
Boston, 02114, United States
Completed
Fairfield, 45014, United States
Terminated
San Diego, 92103-8765, United States
Terminated
Girona, 17007, Spain
Terminated
Sabadell, 08208, Spain
Terminated
Plzen, 301 00, Czech Republic
Terminated
Brno, 656 91, Czech Republic
Terminated
Hradec kralove, 500 05, Czech Republic
Terminated
Praha 2, 128 08, Czech Republic
Terminated
Praha 2, 12808, Czech Republic
Completed
Haifa, 34362, Israel
Terminated
Jerusalem, 9112001, Israel
Terminated
Zalaegerszeg, 8900, Hungary
Completed
Moscow, 119435, Russia
Completed
Moscow, 115093, Russia
Completed
Kaunas, 50009, Lithuania
Completed
Vilnius, 08661, Lithuania
Terminated
Tallin, 13419, Estonia
Terminated
Murska Sobota, 9000, Slovenia
Terminated
Dallas, 75216-7167, United States
Completed
Zabrze, 41-800, Poland
Completed
Szczecin, 70-111, Poland
Completed
Gdansk, 80-211, Poland
Terminated
Barcelona, 08036, Spain
Completed
Majadahonda, 28222, Spain
Terminated
Halifax, B3H 3A7, Canada
Completed
Ste-Foy, G1V 4G5, Canada
Terminated
Toronto, M5B 1W8, Canada
Terminated
Uppsala, 751 85, Sweden
Terminated
Göteborg, 413 45, Sweden
Terminated
Brno, 625 00, Czech Republic
Completed
Zefat, 1311001, Israel
Terminated
Ramat Gan, 5262000, Israel
Completed
Budapest, H-1096, Hungary
Terminated
Debrecen, 4032, Hungary
Terminated
Vac, 2600, Hungary
Terminated
Moscow, 109263, Russia
Terminated
Moscow, 129010, Russia
Terminated
Tartu, 51014, Estonia
Completed
Ljubljana, 1000, Slovenia
Terminated
Golnik, 4204, Slovenia
Terminated
Zagreb, 10000, Croatia
Terminated
Split, 21000, Croatia
Completed
Beograd, 11000, Serbia
Completed
Sremska Kamenica, 21204, Serbia
Completed
Beograd, 11000, Serbia
Terminated
Celje, 3000, Slovenia
Completed
Zagreb, 10000, Croatia
Completed
Beograd, 11000, Serbia

Primary Outcome

  • The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo.
    date_rangeTime Frame:
    8 hours
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Quality of Life
    date_rangeTime Frame:
    Up to 30 days Follow-up
    enhanced_encryption
    Safety Issue:
    no
  • Rehospitalization
    date_rangeTime Frame:
    Up to 30 days Follow-up
    enhanced_encryption
    Safety Issue:
    no
  • 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）
    date_rangeTime Frame:
    Up to 48 hours
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 30 days follow up
    enhanced_encryption
    Safety Issue:
    Yes
  • Plasma concentrations
    date_rangeTime Frame:
    During both the titration and maintenance phases were evaluated.
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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