Trial Condition(s):
Congestive Heart Failure
Placebo controlled, randomized, double-blind, multi-center study to investigate the efficacy and tolerability of BAY58-2667
Bayer Identifier:
12480
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.
Inclusion Criteria
- Patients with decompensated chronic congestive heart failure, NYHA functional class III-IV, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling Swan-Ganz pulmonary artery catheter) and PCWP >/= 18 mmHg. - Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment. - Male or female patients, age 18 years or more.
Exclusion Criteria
- Females of child-bearing potential. - 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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Halle, Germany, 06120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Oeynhausen, Germany, 32545 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Harrow, United Kingdom, HA1 3UJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chesterfield, United Kingdom, S44 5BL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Washington, United States, 20010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 31-202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 50-981 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perugia, Italy, 06156 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ferrara, Italy, 44100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergamo, Italy, 24128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20162 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Nauheim, Germany, 61231 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Homburg, Germany, 66424 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Würzburg, Germany, 97080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greifswald, Germany, 17475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barnet, United Kingdom, EN5 3DJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45219-2316 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fairfield, United States, 45014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92103-8765 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Girona, Spain, 17007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Plzen, Czech Republic, 301 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brno, Czech Republic, 656 91 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hradec kralove, Czech Republic, 500 05 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 128 08 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 34362 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zalaegerszeg, Hungary, 8900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 119435 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 115093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaunas, Lithuania, 50009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, 08661 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tallin, Estonia, 13419 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Murska Sobota, Slovenia, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dallas, United States, 75216-7167 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zabrze, Poland, 41-800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szczecin, Poland, 70-111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gdansk, Poland, 80-211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halifax, Canada, B3H 3A7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ste-Foy, Canada, G1V 4G5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5B 1W8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brno, Czech Republic, 625 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zefat, Israel, 1311001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, H-1096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vac, Hungary, 2600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 109263 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 129010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tartu, Estonia, 51014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ljubljana, Slovenia, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Golnik, Slovenia, 4204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zagreb, Croatia, 10000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Split, Croatia, 21000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beograd, Serbia, 11000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sremska Kamenica, Serbia, 21204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Celje, Slovenia, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zagreb, Croatia, 10000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Placebo controlled, randomized, double-blind, multi-center, multinational Phase IIb study to investigate the efficacy and tolerability of BAY58-2667 given intravenously in patients with decompensated chronic congestive heart failure
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo.Timeframe: 8 hours
Secondary Outcome
- Quality of LifeTimeframe: Up to 30 days Follow-up
- RehospitalizationTimeframe: Up to 30 days Follow-up
- Other hemodynamic measurementsRight atrial pressure (RAP); mean pulmonary artery pressure (PAP mean); pulmonary artery systolic pressure (PASP); pulmonary artery diastolic pressure (PADP); cardiac output (CO); cardiac index (CI); mean arterial pressure (MAP); pulmonary vascular resistance (PVR); pulmonary vascular resistance index (PVRI); systemic vascular resistance (SVR); and systemic vascular resistance index (SVRI）Timeframe: Up to 48 hours
- Safety variablesTreatment-emergent adverse events, laboratory parameters, renal function, in-hospital mortality, length of stay at intensive care unit, and 30-day mortality / morbidity.Timeframe: Up to 30 days follow up
- Plasma concentrationsTimeframe: During both the titration and maintenance phases were evaluated.
Additional Information
Copyright © Bayer
Powered by
