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Sunitinib and Atrial Trabeculae Contractility (SCAR)

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ClinicalTrials.gov Identifier: NCT01246778
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
G. Rongen, Radboud University

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


Condition or disease
Cardiotoxicity Ischemia Heart Failure

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 Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Official Title: The Influence of Sunitinib on Contractility of Human Atrial Trabeculae
Study Start Date : November 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Group/Cohort
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



Primary Outcome Measures :
  1. Force [ Time Frame: 200 minutes ]
    The developed force in ex vivo atrial trabeculae during standardized stimulation.


Secondary Outcome Measures :
  1. Speed [ Time Frame: 200 minutes ]
    The difference in averaged maximal speed of tension reduction during relaxation between two trabeculae

  2. Maximal Speed [ Time Frame: 210 minutes ]
    The difference in averaged maximal speed of tension development during contraction between two trabeculae.


Biospecimen Retention:   None Retained
Atrial tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
44 patients undergoing cardiac surgery with extracorporal circulation
Criteria

Inclusion Criteria:

  • Cardiac surgery with extracorporal circulation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246778


Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: G. A. Rongen Radboud University

Responsible Party: G. Rongen, Prof. dr. Rongen, Radboud University
ClinicalTrials.gov Identifier: NCT01246778     History of Changes
Other Study ID Numbers: SCAR
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Heart Failure
Ischemia
Cardiotoxicity
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors