An observational study in Cardiotoxicity, Ischemia and Heart Failure, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-01.
Sponsored by Radboud University Medical Center · Observational
Rationale:
Recently, sunitinib (a tyrosine kinase inhibitor that is used for treatment of metastatic renal carcinoma and gastrointestinal stroma tumors) has been associated with development of heart failure, possibly by off-target inhibition of AMP-protein kinase. The investigators hypothesize that sunitinib reduces the contractile ability of myocardium and the tolerance against ischemia-reperfusion and that activators of AMP-protein kinase such as atorvastatin and AICAR reverse this unwanted effect of sunitinib.
Objectives:
The primary objective of the study is to investigate the effect of sunitinib on ex-vivo atrial contractile force in absence and presence of ischemia-reperfusion.
A secondary objective is to explore if atorvastatin or AICAR prevent sunitinib-induced deterioration of contractile function of human atrial trabeculas. Study design: Lab
Study population: 44 (+22) patients undergoing CABG cardiac surgery with extracorporal circulation Intervention (if applicable): none (pharmacological interventions will only be performed ex-vivo in isolated atrial tissue) Main study parameters/endpoints The developed force in ex vivo atrial trabeculas during standardized stimulation.
264 studies on the registry are indexed under Cardiotoxicity; 71 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 125 observational studies indexed under Cardiotoxicity.
Browse Cardiotoxicity studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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44 patients undergoing cardiac surgery with extracorporal circulation
Exclusion Criteria:
Two trabeculas will be isolated and one will be exposed to sunitinib and the other to normal buffer solution. Both will be stimulated to contraction during 200 minutes.
Two trabeculas will be isolated and one will be exposed to sunitinib and the other to normal buffer solution. Both will be stimulated to contraction and ischemia/reperfusion
Force
The developed force in ex vivo atrial trabeculae during standardized stimulation.
Time frame: 200 minutes
Speed
The difference in averaged maximal speed of tension reduction during relaxation between two trabeculae
Time frame: 200 minutes
Maximal Speed
The difference in averaged maximal speed of tension development during contraction between two trabeculae.
Time frame: 210 minutes
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center