Efficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.
|First Received Date ICMJE||September 14, 2005|
|Last Updated Date||September 21, 2005|
|Start Date ICMJE||November 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Compare the hemodynamic parameters Cardiac Index (CI) and Pulmonary Capillary Wedge Pressure (PCWP) from baseline to 24 hours, between the two groups.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00219388 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Efficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.|
|Official Title ICMJE||Efficacy and Safety of Short-Term Intravenous Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients Treated With Beta-Receptor Blocking Agents.|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Heart Failure|
|Intervention ICMJE||Drug: Levosimendan|
|Study Arm (s)||Not Provided|
|Publications *||Follath F, Cleland JG, Just H, Papp JG, Scholz H, Peuhkurinen K, Harjola VP, Mitrovic V, Abdalla M, Sandell EP, Lehtonen L; Steering Committee and Investigators of the Levosimendan Infusion versus Dobutamine (LIDO) Study. Efficacy and safety of intravenous levosimendan compared with dobutamine in severe low-output heart failure (the LIDO study): a randomised double-blind trial. Lancet. 2002 Jul 20;360(9328):196-202.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||April 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Main Inclusion Criteria:
Main Exclusion Criteria:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Sweden|
|NCT Number ICMJE||NCT00219388|
|Other Study ID Numbers ICMJE||3001075, Sponsor: Orion Pharma|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Orion Corporation, Orion Pharma|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Orion Corporation, Orion Pharma|
|Verification Date||September 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP