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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iPSC

Genetic

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

Primary outcomes

Cellular gene expression, cellular protein expression, and site directed mutagenesis of induced pluripotent stem cells in response to antihypertensive drugs.

Time frame: 8 years

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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Acronym: PEAR-iPSC

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Sep 17, 2013
Registry last updated: May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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