Sunitinib and Atrial Trabeculae Contractility
SCAR
The Influence of Sunitinib on Contractility of Human Atrial Trabeculae
1 other identifier
observational
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 22, 2010
CompletedFirst Posted
Study publicly available on registry
November 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 1, 2014
April 1, 2014
3.4 years
November 22, 2010
April 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Force
The developed force in ex vivo atrial trabeculae during standardized stimulation.
200 minutes
Secondary Outcomes (2)
Speed
200 minutes
Maximal Speed
210 minutes
Study Arms (2)
With/without sunitinib
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.
With/without sunitinib IP
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
Eligibility Criteria
44 patients undergoing cardiac surgery with extracorporal circulation
You may qualify if:
- Cardiac surgery with extracorporal circulation
You may not qualify if:
- Use of oral antiarrhythmics
- theophylline use
- Use of sulfonylureas
- Atrial arrythmias
- Right ventricular failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB, Netherlands
Biospecimen
Atrial tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
G. A. Rongen
Radboud University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. Rongen
Study Record Dates
First Submitted
November 22, 2010
First Posted
November 23, 2010
Study Start
November 1, 2010
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 1, 2014
Record last verified: 2014-04