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

PHARMACOGENOMIC EVALUATION OF ANTIHYPERTENSIVE RESPONSES IN INDUCED PLURIPOTENT STEM (IPS) CELLS STUDY (PEAR-IPSC) (PEAR-iPSC)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Genetic: iPSC

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study participants recruited from the Pharmacogenomic Evaluation of Antihypertensive Responses studies; PEAR (#201-2005) and PEAR-2 (#271-2010) funded by the National Institutes of Health. Participants in the study have completed either PEAR or PEAR-2 studies

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diuretic; Patients who received a diuretic drug during the parent trial are eligible for participation.	Genetic: iPSC; Single blood draw for the production of induced pluripotent stem cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular gene expression, cellular protein expression, and site directed mutagenesis of induced pluripotent stem cells in response to antihypertensive drugs.	iPSC cells will be used to model the mechanisms by which genetic differences influence responses to antihypertensive drugs. Potential methods included cellular gene expression, cellular protein expression, and site directed mutagenesis.	8 years

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2013
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (ESTIMATE): September 17, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: IRB201600901; 093-2013 (OTHER: IRB)