stop_circleTerminated/Withdrawn

Acute Heart Failure

Bayer Identifier:

14663

ClinicalTrials.gov Identifier:

NCT01067859

EudraCT Number:

2009-014378-16

EU CT Number:

Not Available
A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to 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 Congestive Heart Failure (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
5
Trial Dates
March 2010 - November 2010
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Cinaciguat (BAY58-2667)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
University of CincinnatiCincinnati, 45267-0542, United States
Terminated
Hôpital de Rangueil - ToulouseTOULOUSE, 31403, France
Terminated
Hôpital Erasme/Erasmus ZiekenhuisBRUXELLES - BRUSSEL, 1070, Belgium
Terminated
Sanatorio MitreBuenos Aires, C1039AAO, Argentina
Terminated
Beaumont HospitalDublin, DUBLIN 9, Ireland
Completed
Herz- und Diabeteszentrum Nordrhein-WestfalenBad Oeynhausen, 32545, Germany
Terminated
Herzzentrum Bad KrozingenBad Krozingen, 79189, Germany
Terminated
DRK Kliniken Berlin - KöpenickBerlin, 12559, Germany
Completed
Kerckhoff-Klinik GmbHBad Nauheim, 61231, Germany
Terminated
Medizinische Einrichtungen der Heinrich-Heine-UniversitätDüsseldorf, 40225, Germany
Terminated
Hopital LARIBOISIEREPARIS cedex 10, 75475, France
Terminated
Centre Hospitalier Regional Henri MondorCreteil, 94010, France
Terminated
OL Vrouwziekenhuis - Campus AalstAALST, 9300, Belgium
Terminated
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Terminated
Fundación FavaloroBuenos Aires, 1078, Argentina
Terminated
LKH Graz WestGraz, 8020, Austria
Terminated
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Terminated
Massachusetts General HospitalBoston, 02114, United States
Terminated
Albert Einstein Health NetworkPhiladelphia, 19141, United States
Terminated
University of Alabama at BirminghamBirmingham, 35294, United States
Terminated
Shands Jacksonville Medical CenterJacksonville, 32209, United States
Terminated
Ohio State University Medical CenterColumbus, 43210, United States
Terminated
Hospital General “Dr Gustavo Baz Prada”Mexico D.F., 57000, Mexico
Terminated
PulmocriticGuadalajara, 44670, Mexico
Terminated
Instituto Nacional de Cardiología "Ignacio Chávez"México D.F., Mexico
Terminated
Instituto Cardiovascular de Buenos AiresBuenos Aires, C1428DCO, Argentina
Terminated
Philippine Heart CentreQuezon City, 1102, Philippines
Terminated
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Guadalajara, 44280, Mexico
Terminated
Sanatorio Modelo QuilmesQuilmes, Argentina
Terminated
Hospital Italiano Buenos AiresBuenos Aires, C1181ACH, Argentina

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 (after 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 Low Dose BAY58-2667 (25 µg/h, 10 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
3

Additional Information

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