Sunitinib and Atrial Trabeculae Contractility

Completed

• Conditions: Cardiotoxicity; Ischemia; Heart Failure

• Registration Number: NCT01246778
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Cardiac surgery with extracorporal circulation

Exclusion Criteria

• Use of oral antiarrhythmics
• theophylline use
• Use of sulfonylureas
• Atrial arrythmias
• Right ventricular failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Force	200 minutes	The developed force in ex vivo atrial trabeculae during standardized stimulation.

Secondary Outcome Measures

Name	Time	Method
Speed	200 minutes	The difference in averaged maximal speed of tension reduction during relaxation between two trabeculae
Maximal Speed	210 minutes	The difference in averaged maximal speed of tension development during contraction between two trabeculae.

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands