Trial Condition(s):
Acute Heart Failure
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) (COMPOSE 2)
Bayer Identifier:
14663
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 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
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 University of Cincinnati Cincinnati, United States, 45267-0542 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de Rangueil - Toulouse TOULOUSE, France, 31403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sanatorio Mitre Buenos Aires, Argentina, C1039AAO | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beaumont Hospital Dublin, Ireland, DUBLIN 9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Herz- und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen, Germany, 32545 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Herzzentrum Bad Krozingen Bad Krozingen, Germany, 79189 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations DRK Kliniken Berlin - Köpenick Berlin, Germany, 12559 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kerckhoff-Klinik GmbH Bad Nauheim, Germany, 61231 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Heinrich-Heine-Universität Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital LARIBOISIERE PARIS cedex 10, France, 75475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Regional Henri Mondor Creteil, France, 94010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OL Vrouwziekenhuis - Campus Aalst AALST, Belgium, 9300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Favaloro Buenos Aires, Argentina, 1078 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations LKH Graz West Graz, Austria, 8020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Massachusetts General Hospital Boston, United States, 02114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Albert Einstein Health Network Philadelphia, United States, 19141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alabama at Birmingham Birmingham, United States, 35294 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shands Jacksonville Medical Center Jacksonville, United States, 32209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ohio State University Medical Center Columbus, United States, 43210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General “Dr Gustavo Baz Prada” Mexico D.F., Mexico, 57000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pulmocritic Guadalajara, Mexico, 44670 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Nacional de Cardiología "Ignacio Chávez" México D.F., Mexico | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Cardiovascular de Buenos Aires Buenos Aires, Argentina, C1428DCO | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Philippine Heart Centre Quezon City, Philippines, 1102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara, Mexico, 44280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sanatorio Modelo Quilmes Quilmes, Argentina | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Italiano Buenos Aires Buenos Aires, Argentina, C1181ACH | 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 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
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 (after 30+5 days)
- Right atrial pressure (RAP)Timeframe: 8 hours and 48 hours
Additional Information
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