Sunitinib and Atrial Trabeculae Contractility

Heart Failure Clinical Trial

— SCAR  

Official title:

The Influence of Sunitinib on Contractility of Human Atrial Trabeculae

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246778
• Other study ID #: SCAR
• Status: Completed
• Phase: N/A
• First received: November 22, 2010
• Last updated: April 30, 2014
• Start date: November 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only

Related Conditions & MeSH terms

• Cardiotoxicity
• Heart Failure
• Ischemia

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Force	The developed force in ex vivo atrial trabeculae during standardized stimulation.	200 minutes	No
Secondary	Speed	The difference in averaged maximal speed of tension reduction during relaxation between two trabeculae	200 minutes	No
Secondary	Maximal Speed	The difference in averaged maximal speed of tension development during contraction between two trabeculae.	210 minutes	No