NCT01246778

Sunitinib and Atrial Trabeculae Contractility

The Influence of Sunitinib on Contractility of Human Atrial Trabeculae

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Cardiotoxicity
• Ischemia
• Heart Failure

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-11-23
• Last updated: 2014-05-01

Locations

1 site across 1 country: Netherlands