stop_circleTerminated/Withdrawn

Acute Heart Failure

Bayer Identifier:

14560

ClinicalTrials.gov Identifier:

NCT01065077

EudraCT Number:

2009-014377-40

EU CT Number:

Not Available
BAY58-2667 dose finding trial investigating fixed doses in patients with acute decompensated chronic congestive heart failure (ADHF)

Trial purpose

A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
    - Subjects must have the clinical diagnosis of CHF made at least three months prior to enrollment
    - Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:
     -- dyspnea and
     -- clinical evidence of volume overload
  • - 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
    - Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
    - Primary hypertrophic cardiomyopathy
    - Acute inflammatory heart disease, eg, acute myocarditis
    - Unstable angina requiring angiography

Trial summary

Enrollment Goal
12
Trial Dates
March 2010 - February 2011
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Cinaciguat (BAY58-2667)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
HELIOS Klinikum Erfurt GmbHErfurt, 99089, Germany
Completed
Universitätskliniken des SaarlandesHomburg, 66424, Germany
Terminated
CSK MSWiAWarszawa, 02-507, Poland
Terminated
St. Marianna University of School Medicine HospitalKawasaki, 216-8511, Japan
Terminated
Kure Medical CenterKure, 737-0023, Japan
Terminated
Nagasaki Medical CenterOmura, 856-8562, Japan
Completed
A.O.U. di FerraraFerrara, 44100, Italy
Completed
A.O. Spedali Civili di BresciaBrescia, 25100, Italy
Terminated
A.O. Carlo PomaMantova, 46100, Italy
Terminated
Hadassah University Hospital Ein KeremJerusalem, 91120, Israel
Terminated
Poria HospitalTiberias, 31905, Israel
Terminated
Krankenhaus der Elisabethinen LinzLinz, 4010, Austria
Terminated
1st Moscow Medical Academy named after I.M. SechenovMoscow, 119881, Russia
Terminated
Regional State Medical InstitutionKrasnoyarsk, 660022, Russia
Terminated
Vseobecna nemocnica s poliklinikou LucenecLucenec, 984 39, Slovakia
Terminated
Medizinische Einrichtungen der Universität zu KölnKöln, 50924, Germany
Completed
Klinikum der Friedrich-Schiller-Universität JenaJena, 07740, Germany
Completed
Klinikum der Ernst-Moritz-Arndt-UniversitätGreifswald, 17475, Germany
Terminated
Instytut KardiologiiWarszawa, 04-628, Poland
Completed
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZWroclaw, 50-981, Poland
Terminated
Uniwersyteckie Centrum KliniczneGdansk, 80-211, Poland
Terminated
Wielospecjalistyczny Szpital SP ZOZZgorzelec, 59-900, Poland
Terminated
Mito Medical CenterHigashiibaraki, 311-3193, Japan
Terminated
Showa University HospitalShinagawa, 142-8666, Japan
Terminated
Nippon Medical School HospitalBunkyo-ku, 113-8603, Japan
Terminated
Nagoya Medical CenterNagoya, 460-0001, Japan
Terminated
A.O. Sant' AnnaSan Fermo della Battaglia, 22020, Italy
Terminated
A.O.U. S.G.Battista-MolinetteTorino, 10126, Italy
Terminated
Akademiska SjukhusetUppsala, 751 85, Sweden
Terminated
Universitätsspital ZürichZürich, 8091, Switzerland
Terminated
Ramathibodhi HospitalBangkok, 10400, Thailand
Terminated
General Hospital CeljeCelje, 3000, Slovenia
Terminated
Emergency Institute for Cardiovascular DiseasesBucharest, 022328, Romania
Terminated
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Terminated
Lady Davis Carmel Medical CenterHaifa, 34362, Israel
Terminated
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Terminated
Municipal Hospital N 4Moscow, 115093, Russia
Terminated
Municipal Hospital N 68Moscow, 109263, Russia
Terminated
Univerzitna nemocnica MartinMartin, 036 59, Slovakia
Terminated
Ospedale regionale di LuganoLugano, 6900, Switzerland
Terminated
HUS, Meilahden sairaalaHelsinki, 00029, Finland
Terminated
Oulun yliopistollinen sairaalaOulu, 90220, Finland
Terminated
Pramongkutklao HospitalBangkok, 10400, Thailand
Terminated
Klinicni centerLjubljana, 1000, Slovenia
Terminated
Hospital GolnikGolnik, 4204, Slovenia
Terminated
Mercy Hospital FairfieldFairfield, 45014, United States
Terminated
Slaskie Centrum Chorob SercaZabrze, 41-800, Poland
Terminated
Wojewodzki Szpital Specjalistyczny im. BieganskiegoLodz, 91-347, Poland
Terminated
Osaka Police HospitalOsaka, 543-0035, Japan
Terminated
Klinicka Bolnica Sestre MilosrdniceZagreb, 10000, Croatia
Terminated
Klinicki Bolnicki Centar ZagrebZagreb, 10000, Croatia
Terminated
Opca bolnica Sveti DuhZagreb, 10000, Croatia
Terminated
Klinicki Centar NisNis, 18000, Serbia
Terminated
Institut za kardiovaskularne bolesti DedinjeBeograd, 11000, Serbia
Terminated
Klinicki centar SrbijeBeograd, 11000, Serbia
Terminated
Klinicki centar SrbijeBeograd, 11000, Serbia
Terminated
Institute za kardiovaskularne bolesti VojvodineSremska Kamenica, 21204, Serbia
Terminated
Institut za kardiovaskularne bolesti DedinjeBeograd, 11000, Serbia
Terminated
Institut za kardiovaskularne bolesti DedinjeBeograd, 11000, Serbia
Terminated
Institut za kardiovaskularne bolesti DedinjeBeograd, 11000, Serbia
Terminated
Louis Stokes VA Medical CenterCleveland, 44106, United States
Terminated
Drexel University College of MedicinePhiladelphia, 19102, United States
Terminated
Valley HospitalRidgewood, 07450, United States
Terminated
Jefferson Heart InstitutePhiladelphia, 19107, United States
Terminated
Wake Forest University School of MedicineWinston-Salem, 27157, United States
Terminated
Institutul Inimii de Urgenta pentru Boli CardiovasculareCluj-Napoca, 400001, Romania

Primary Outcome

  • Pulmonary Capillary Wedge Pressure
    date_rangeTime Frame:
    8 hours
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Cardiac index (CI)
    date_rangeTime Frame:
    8 hours and 48 hours
    enhanced_encryption
    Safety Issue:
    no
  • Kansas City Cardiomyopathy Questionnaire (KCCQ)
    date_rangeTime Frame:
    Follow up (30 + 5 days)
    enhanced_encryption
    Safety Issue:
    no
  • Right atrial pressure (RAP)
    date_rangeTime Frame:
    8 hours and 48 hours
    enhanced_encryption
    Safety Issue:
    no

Trial design

A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY58-2667 (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects with Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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