HypertensionPEAR-iPSCNCT01943383
Pharmacogenomic Evaluation of Antihypertensive Responses in Induced Pluripotent Stem (iPS) Cells Study
An observational study of Hypertension, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- iPSC
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- participation in the parent trial PEAR (201-2005) or PEAR2 (271-2010)
- assigned to a diuretic arm
Who cannot join
- no participation in the parent trial PEAR (201-2005) or PEAR2 (271-2010)
- assigned to a beta blocker arm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- iPSC
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPSCGenetic
Single blood draw for the production of induced pluripotent stem cells.
| Study group | Role | What they receive |
|---|---|---|
| Diuretic | Patients who received a diuretic drug during the parent trial are eligible for participation. Receives: Genetic: iPSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie A Johnson, PharmD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943383
- Sponsor's protocol ID
- IRB201600901
- Other IDs
- 093-2013
- Acronym
- PEAR-iPSC
- Status last verified
- May 2018
- First submitted
- 27 Aug 2013
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHARMACOGENOMIC EVALUATION OF ANTIHYPERTENSIVE RESPONSES IN INDUCED PLURIPOTENT STEM (IPS) CELLS STUDY (PEAR-IPSC) (PEAR-iPSC)
- ClinicalTrials.gov ID
- NCT01943383
- Acronym / sponsor ID
- PEAR-iPSC / IRB201600901
- Conditions
- Hypertension
- Keywords
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diuretic | – | Genetic: iPSCPatients who received a diuretic drug during the parent trial are eligible for participation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- participation in the parent trial PEAR (201-2005) or PEAR2 (271-2010)
- assigned to a diuretic arm
Key exclusion criteria (2 listed)
- no participation in the parent trial PEAR (201-2005) or PEAR2 (271-2010)
- assigned to a beta blocker arm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPSCSingle blood draw for the production of induced pluripotent stem cells. | Genetic | Diuretic |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Johnson, PharmD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular gene expression, cellular protein expression, and site directed mutagenesis of induced pluripotent stem cells in response to antihypertensive drugs. (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.