Clinical trial NCT01065077: BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Heart Failure
Keywords: Heart Failure
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pulmonary Capillary Wedge Pressure
timeFrame: 8 hours
Secondary outcomes:
measure: Cardiac index (CI)
timeFrame: 8 hours and 48 hours
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Follow up (30 + 5 days)
measure: Right atrial pressure (RAP)
timeFrame: 8 hours and 48 hours
Other outcomes:
Locations:
city: Ridgewood
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Linz
country: Austria
state: Oberösterreich
city: Wien
country: Austria
city: Zagreb
country: Croatia
city: Helsinki
country: Finland
city: Oulu
country: Finland
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Homburg
country: Germany
state: Saarland
city: Erfurt
country: Germany
state: Thüringen
city: Jena
country: Germany
state: Thüringen
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Tiberias
country: Israel
city: San Fermo della Battaglia
country: Italy
state: Como
city: Brescia
country: Italy
city: Ferrara
country: Italy
city: Mantova
country: Italy
city: Torino
country: Italy
city: Nagoya
country: Japan
state: Aichi
city: Kure
country: Japan
state: Hiroshima
city: Higashiibaraki
country: Japan
state: Ibaraki
city: Kawasaki
country: Japan
state: Kanagawa
city: Omura
country: Japan
state: Nagasaki
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Osaka
country: Japan
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zabrze
country: Poland
city: Zgorzelec
country: Poland
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Krasnoyarsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Beograd
country: Serbia
city: Nis
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Lucenec
country: Slovakia
city: Martin
country: Slovakia
city: Celje
country: Slovenia
city: Golnik
country: Slovenia
city: Ljubljana
country: Slovenia
city: Göteborg
country: Sweden
city: Uppsala
country: Sweden
city: Lugano
country: Switzerland
state: Ticino
city: Zürich
country: Switzerland
city: Bangkok
country: Thailand
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Gheorghiade M, Greene SJ, Filippatos G, Erdmann E, Ferrari R, Levy PD, Maggioni A, Nowack C, Mebazaa A; COMPOSE Investigators and Coordinators. Cinaciguat, a soluble guanylate cyclase activator: results from the randomized, controlled, phase IIb COMPOSE programme in acute heart failure syndromes. Eur J Heart Fail. 2012 Sep;14(9):1056-66. doi: 10.1093/eurjhf/hfs093. Epub 2012 Jun 19.