NCT01593579

Autonomic Phenotype Before and After Akt Inhibition

Autonomic Phenotype Before and After Akt Inhibition: Akt Therapy for Melanoma Sub-study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Some Akt inhibitors have produced functional cardiovascular effects such as marked hypotension that may limit their clinical benefit. There are no current data on whether this autonomic failure presents in humans at clinically used doses. We will test the hypothesis that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.

Conditions

• Diagnosis of Melanoma

Interventions

Type	Name	Description
BEHAVIORAL	Autonomic Function Tests	Patients will undergo Autonomic Function testing (AFT) before and 8 hours after Akt Inhibition therapy. AFT includes: Supine \& standing heart rate \& blood pressure, 10 minute head up tilt, cardiac output, sinus arrhythmia, hyperventilation, sustained handgrip, valsalva manuever, and cold pressor test.
OTHER	supine and standing catecholamines	patients will have blood drawn from supine and standing catecholamines.

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-05-01
• Completion: 2016-05-01
• First posted: 2012-05-08
• Last updated: 2014-12-23

Locations

1 site across 1 country: United States