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Sunitinib and Atrial Trabeculae Contractility (SCAR)

This study is currently recruiting participants.
Verified January 2013 by Radboud University
Sponsor:
Information provided by (Responsible Party):
G. Rongen, Radboud University
ClinicalTrials.gov Identifier:
NCT01246778
First received: November 22, 2010
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Cardiotoxicity
Ischemia
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: The Influence of Sunitinib on Contractility of Human Atrial Trabeculae

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Scars
U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Force [ Time Frame: 200 minutes ] [ Designated as safety issue: No ]
    The developed force in ex vivo atrial trabeculae during standardized stimulation.


Secondary Outcome Measures:
  • Speed [ Time Frame: 200 minutes ] [ Designated as safety issue: No ]
    The difference in averaged maximal speed of tension reduction during relaxation between two trabeculae

  • Maximal Speed [ Time Frame: 210 minutes ] [ Designated as safety issue: No ]
    The difference in averaged maximal speed of tension development during contraction between two trabeculae.


Biospecimen Retention:   Samples With DNA

Atrial tissue


Estimated Enrollment: 44
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
With sunitinib and with/without statin
Two trabeculas will be isolated and both will be exposed to sunitinib and one will be exposed to atorvastatin and the other to normal buffer solution. Both will be stimulated to contraction and ischemia/reperfusion
With sunitinib with or without AICAR
Two trabeculas will be isolated and both will be exposed to sunitinib and one will be exposed to AICAR and the other to normal buffer solution. Both will be stimulated to contraction and ischemia/reperfusion

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246778

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500HB
Contact: Annemarie Thijs, MD     +31243613690     a.thijs@aig.umcn.nl    
Principal Investigator: Gerard Rongen, MD PhD            
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: G. A. Rongen Radboud University
  More Information

No publications provided

Responsible Party: G. Rongen, Prof. dr. Rongen, Radboud University
ClinicalTrials.gov Identifier: NCT01246778     History of Changes
Other Study ID Numbers: SCAR
Study First Received: November 22, 2010
Last Updated: January 8, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Heart Failure
Ischemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sunitinib
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013