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Trial NCT00219388

Resource URI: http://static.linkedct.org/resource/trials/NCT00219388
linkedct:brief_title Efficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.
linkedct:condition <http://static.linkedct.org/resource/condition/5704>
linkedct:criteria Main Inclusion Criteria: - Decompensated chronic heart failure of ischemic or non-ischemic origin, in NYHA class III to IV, despite optimised conventional treatment and who may benefit from intravenous positive inotropic agents as per the investigator’s judgment. - Ongoing treatment with a beta-receptor blocking agent in a stable regimen for at least 3 months and at an optimal dose as per the investigator’s judgment. - Left ventricular (LV) ejection fraction (EF) less than or similar to 35%. - CI < 2.5 l/min/m2. - Mean PCWP >15 mmHg. Main Exclusion Criteria: - Significant mechanical obstruction affecting ventricular filling and/or outflow. - Systolic blood pressure 85 mmHg or less at screening and/or baseline. - Heart rate 130 bpm or greater, persistent for at least 5 minutes at screening and/or baseline. - Severe angina pectoris during the 6 hours before screening and/or baseline. - Deterioration of chronic heart failure due to an acute myocardial infarction within 5 days before screening measurements. - Administration of Simdax within 1 month before baseline. - A history of Torsades de Pointes. - Evidence of severe renal insufficiency (serum creatinine > 450 mol/l or on dialysis) at screening. - Significant hepatic impairment or elevation of liver enzymes to 5 times the upper limit of normal range of the analysing laboratory at screening. - Acute bleeding or severe anaemia. - Heart surgery within 3 months before baseline.
linkedct:description Patients with decompensate heart failure (NYHA III-IV) and in need of intravenous inotrop support and who fulfil all inclusion and no exclusion criteria will be randomised into the study in proportion 1:1. Although stratification will be done so patients treated with beta-receptor blocker carvedilol will be divided the same between the study groups. All patients will receive infusions in parallell, one of the groups will receive active product (levosimendan or dobutamine) and the other will receive placebo (double-dummy technique). Catheterisation for measurement of hemodynamic parameters will be performed according to routine methods at the clinic. The measurements of the hemodynamic variables will start 30 minutes before start of study drug infusion and will be finished 48 hours after start of infusion. The most important variables during the measurements is Cardiac Index (CI)and Pulmonary Capillary Wedge Pressure (PCWP). Parallel registration will be done on ECG, blood pressure, blood frequency, central venous pressure, and lung artery pressure. Heart failure and other clinical symptoms will be registered continuously during 48 hours. Blood samples will be taken intermittent to record the blood values. Cogent rules for decreasing/increasing of the dose can be found in the study protocol, likewise rules for interruption or stoop for infusion. Registration of side-effects will be done continuously. The recommendation for treatment for known side effects could be found in the protocol (section 5.3.4) and the protocol should be available during the study procedure. One month after the study the patients will be followed up with a very careful examination and also of the amount of visits and reason for visits to hospital during the past 30-35 days.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date April 2005
linkedct:enrollment 60 (xsd:int)
linkedct:firstreceived_date September 14, 2005
linkedct:id NCT00219388
rdfs:label Trial NCT00219388
linkedct:lastchanged_date September 21, 2005
linkedct:lead_sponsor_agency Orion Corporation, Orion Pharma
linkedct:location <http://static.linkedct.org/resource/location/119942>
linkedct:nct_id NCT00219388
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Efficacy and Safety of Short-Term Intravenous Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients Treated With Beta-Receptor Blocking Agents.
linkedct:org_study_id 3001075
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10027>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2573>
foaf:page <http://clinicaltrials.gov/show/NCT00219388>
linkedct:phase Phase 4
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/5080>
linkedct:reference <http://static.linkedct.org/resource/reference/14194>
linkedct:secondary_id Sponsor: Orion Pharma
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/13>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/189>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/29274>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/44>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/45>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/46>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/49>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/61>
linkedct:source Orion Corporation, Orion Pharma
linkedct:start_date November 2002
linkedct:study_design Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to compare the effects of levosimendan with dobutamine on heart function in patients suffering of severe chronic heart failure.
rdf:type linkedct:trials
linkedct:verification_date September 2005