Pharmacogenomic Evaluation of Antihypertensive Responses in Induced Pluripotent Stem (iPS) Cells Study

NCT ID: NCT01943383

Last Updated: 2018-05-31

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

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-05-31

Brief Summary

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Patients enrolled in this study will have completed one of the parent studies "Pharmacogenomic Evaluation of Antihypertensive Responses" (PEAR-1 or PEAR-2) evaluating how well their blood pressure was controlled by medication. Patients in the current study will provide a single tube of blood which will be used to create adult stem cells that can be converted into other cell types, like heart or vasculature. Patients will not be asked to return for any follow up visits.

Detailed Description

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If the patient decide to participate in this study, they will have 1 visit for the study that will include a blood draw. Upon arrival to the clinic, the study will be explained to the patient in detail. The patient will be asked at that time to sign this consent form. The patient will have the opportunity to ask questions and the research staff will answer those questions. If the patient decides to participate in this study and sign a consent form, then a blood sample will be collected from a vein in the arm. A total of 2 teaspoons full of blood will be drawn for the study.

During this visit, in addition to collecting a blood sample, patients will be asked about their medical history and medications they are currently taking, and will have their vital signs assessed, including blood pressure, pulse, and temperature.

Blood will be drawn by a trained nurse or a phlebotomist at a family medicine clinic in Gainesville, Florida. The blood sample will be further processed in laboratories at the University of Florida, for the establishment of iPS cells. iPS cells will retain the patient's genetic makeup which makes them useful for research. Several experiments will be conducted on these cells that will provide data that can be used to learn more about how genetic markers can lead to differences in blood pressure response to medicines. These cells will be used for up to 8 years.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diuretic

Patients who received a diuretic drug during the parent trial are eligible for participation.

iPSC

Intervention Type GENETIC

Single blood draw for the production of induced pluripotent stem cells.

Interventions

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iPSC

Single blood draw for the production of induced pluripotent stem cells.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* participation in the parent trial PEAR (201-2005) or PEAR2 (271-2010)
* assigned to a diuretic arm

Exclusion Criteria

* no participation in the parent trial PEAR (201-2005) or PEAR2 (271-2010)
* assigned to a beta blocker arm
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie A Johnson, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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093-2013

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201600901

Identifier Type: -

Identifier Source: org_study_id

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