Trial Condition(s):
Acute Heart Failure
BAY58-2667 dose finding trial investigating fixed doses in patients with acute decompensated chronic congestive heart failure (ADHF) (COMPOSE 1)
Bayer Identifier:
14560
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations HELIOS Klinikum Erfurt GmbH Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätskliniken des Saarlandes Homburg, Germany, 66424 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CSK MSWiA Warszawa, Poland, 02-507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Marianna University of School Medicine Hospital Kawasaki, Japan, 216-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kure Medical Center Kure, Japan, 737-0023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagasaki Medical Center Omura, Japan, 856-8562 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Ferrara Ferrara, Italy, 44100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Spedali Civili di Brescia Brescia, Italy, 25100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Carlo Poma Mantova, Italy, 46100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hadassah University Hospital Ein Kerem Jerusalem, Israel, 91120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Poria Hospital Tiberias, Israel, 31905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus der Elisabethinen Linz Linz, Austria, 4010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Moscow Medical Academy named after I.M. Sechenov Moscow, Russia, 119881 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional State Medical Institution Krasnoyarsk, Russia, 660022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vseobecna nemocnica s poliklinikou Lucenec Lucenec, Slovakia, 984 39 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität zu Köln Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Friedrich-Schiller-Universität Jena Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Ernst-Moritz-Arndt-Universität Greifswald, Germany, 17475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instytut Kardiologii Warszawa, Poland, 04-628 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ Wroclaw, Poland, 50-981 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersyteckie Centrum Kliniczne Gdansk, Poland, 80-211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wielospecjalistyczny Szpital SP ZOZ Zgorzelec, Poland, 59-900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mito Medical Center Higashiibaraki, Japan, 311-3193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Showa University Hospital Shinagawa, Japan, 142-8666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nippon Medical School Hospital Bunkyo-ku, Japan, 113-8603 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagoya Medical Center Nagoya, Japan, 460-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Sant' Anna San Fermo della Battaglia, Italy, 22020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. S.G.Battista-Molinette Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademiska Sjukhuset Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Zürich Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ramathibodhi Hospital Bangkok, Thailand, 10400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations General Hospital Celje Celje, Slovenia, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Emergency Institute for Cardiovascular Diseases Bucharest, Romania, 022328 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lady Davis Carmel Medical Center Haifa, Israel, 34362 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Municipal Hospital N 4 Moscow, Russia, 115093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Municipal Hospital N 68 Moscow, Russia, 109263 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Univerzitna nemocnica Martin Martin, Slovakia, 036 59 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale regionale di Lugano Lugano, Switzerland, 6900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HUS, Meilahden sairaala Helsinki, Finland, 00029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oulun yliopistollinen sairaala Oulu, Finland, 90220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pramongkutklao Hospital Bangkok, Thailand, 10400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinicni center Ljubljana, Slovenia, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Golnik Golnik, Slovenia, 4204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mercy Hospital Fairfield Fairfield, United States, 45014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Slaskie Centrum Chorob Serca Zabrze, Poland, 41-800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. Bieganskiego Lodz, Poland, 91-347 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka Police Hospital Osaka, Japan, 543-0035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinicka Bolnica Sestre Milosrdnice Zagreb, Croatia, 10000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinicki Bolnicki Centar Zagreb Zagreb, Croatia, 10000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Opca bolnica Sveti Duh Zagreb, Croatia, 10000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinicki Centar Nis Nis, Serbia, 18000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut za kardiovaskularne bolesti Dedinje Beograd, Serbia, 11000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinicki centar Srbije Beograd, Serbia, 11000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute za kardiovaskularne bolesti Vojvodine Sremska Kamenica, Serbia, 21204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Louis Stokes VA Medical Center Cleveland, United States, 44106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Drexel University College of Medicine Philadelphia, United States, 19102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Valley Hospital Ridgewood, United States, 07450 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jefferson Heart Institute Philadelphia, United States, 19107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wake Forest University School of Medicine Winston-Salem, United States, 27157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institutul Inimii de Urgenta pentru Boli Cardiovasculare Cluj-Napoca, Romania, 400001 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Pulmonary Capillary Wedge PressureTimeframe: 8 hours
Secondary Outcome
- Cardiac index (CI)Timeframe: 8 hours and 48 hours
- Kansas City Cardiomyopathy Questionnaire (KCCQ)Timeframe: Follow up (30 + 5 days)
- Right atrial pressure (RAP)Timeframe: 8 hours and 48 hours
Additional Information
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