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OpenTrials
Completed

NCT Number: NCT01246778

Sunitinib and Atrial Trabeculae Contractility

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

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Key information

Conditions

Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Heart Failure Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cardiac surgery with extracorporal circulation

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Force

    Time frame: 200 minutes

    The developed force in ex vivo atrial trabeculae during standardized stimulation.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

The Influence of Sunitinib on Contractility of Human Atrial Trabeculae

Acronym: SCAR

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 23, 2010
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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