Sunitinib and Atrial Trabeculae Contractility

The Influence of Sunitinib on Contractility of Human Atrial Trabeculae

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01246778

Acronym

SCAR

Enrollment

Registered

2010-11-23

Start date

2010-11-30

Completion date

2014-04-30

Last updated

2014-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity, Heart Failure, Ischemia

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Cardiac surgery with extracorporal circulation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Force	200 minutes	The developed force in ex vivo atrial trabeculae during standardized stimulation.

Secondary

Measure	Time frame	Description
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.

Countries

Netherlands

Outcome results