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Autonomic Phenotype Before and After Akt Inhibition

NCT ID: NCT01593579

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diagnosis of Melanoma

Keywords

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melanoma autonomic failure hypotension akt therapy

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Melanoma

Patients with Melanoma that are enrolled in a clinical trial at the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor

Autonomic Function Tests

Intervention Type BEHAVIORAL

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.

supine and standing catecholamines

Intervention Type OTHER

patients will have blood drawn from supine and standing catecholamines.

Interventions

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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.

Intervention Type BEHAVIORAL

supine and standing catecholamines

patients will have blood drawn from supine and standing catecholamines.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with melanoma with a BRAF mutation and relapse following therapy with a BRAF inhibitor
* Enrolled in a clinical trial through the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor
* Able and willing to provide informed consent

Exclusion Criteria

* Factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
* Unable to give informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Satish R. Raj

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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VR3689

Identifier Type: OTHER

Identifier Source: secondary_id

120390

Identifier Type: -

Identifier Source: org_study_id