Cardiovascular Effects of Sunitinib Therapy (CREST)

Completed

Conditions studied: Renal Cell Carcinoma 4

In brief

Tyrosine kinase inhibitors such as sunitinib are used in the treatment of renal cell carcinoma and have significant off-target effects with cardiac toxicity and resultant ventricular cardiac dysfunction being a major concern. However, the mechanisms of these effects in humans remains poorly defined, as are the clinical methods to risk stratify and identify patients who will ultimately suffer from cardiac dysfunction. The goal of this multi-center study is to characterize the cardiovascular measures of cardiac function; 2) comprehensive measures of arterial function and left ventricular afterload; 3) biomarkers reflective of the pathophysiologic alterations. Through this work, the investigators will translate our basic understanding of sunitinib cardiotoxicity to humans and identify early predictors of sunitinib cardiotoxicity.

Key facts

Study ID

NCT01370109

Run by

Abramson Cancer Center at Penn Medicine

People needed

98

Starts

2011-04-01

Expected to finish

2017-12-31

Last updated by the study team

2018-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with renal cell carcinoma newly undergoing therapy with sunitinib.
• Age greater than or equal to 18 years
• ECOG performance status 0,1,2

You may not qualify if…

• Any contraindication to sunitinib therapy of note, patients with prior cardiovascular history are not excluded from this study, as long as there are no contraindications to sunitinib therapy.

Where it is running

• Abramson Cancer Center, University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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