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Autonomic Phenotype Before and After Akt Inhibition

NCT01593579 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2014-12-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593579 on ClinicalTrials.gov