HypertensionNCT00522119
Analysis of Genes That Predispose People to Develop High Blood Pressure
An observational study of Hypertension, run by University of Maryland, Baltimore.
Trial summary
High blood pressure affects nearly one third of all individuals in the United States. It is believed that genetic factors may predispose some people to develop this disease. This study will identify and characterize variations in three genes known to play a part in the development of high blood pressure. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 868 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Jul 2011
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Characteristic Men (n = 460) Women (n = 408) Age (y) 42.2 ± 0.6 45.4 ± 0.7 BMI (kg/m2) 25.6 ± 0.1 27.8 ± 0.3 TCHOL (mg/dL) 202.5 ± 2.1 215.7 ± 2.5 HDL (mg/dL) 52.6 ± 0.6 59.5 ± 0.8 TG (mg/dL) 63.9 ± 1.7 73.8 ± 2.3 SBP (mm Hg) 121.5 ± 0.6 121.4 ± 0.8 DBP (mm Hg) 77.6 ± 0.4 75.8 ± 0.4 Diabetes (%) 0.9 1.0 Current smokers (%) 20.0 0.0 * on lipid-lowering medications 1.1 1.0 * on antihypertensive medications 0.2 0.3
Who may be able to join
- Amish individuals from the Lancaster community in PA.
- Study-wide Exclusion criteria:
- Age< 20 yrs
- Non-Amish descent
- Currently pregnant or postpartum <6 m
- Blood pressure at the time of screening >180/105 (SBB/DBP) mm Hg
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- Prescription medication use potentially affecting outcomes and vitamin or over-the-counter remedies that cannot be willingly or safely discontinued from 1 week before protocol initiation and until the end of the study (ie, β-blockers; calcium channel antagonists; ACE inhibitors; diuretics; lipid-lowering agents; nitrates; systemic glucocorticoids; adrenergic or cholinergic-acting agents, including cold formulas and antidepressants; and diet-weight loss agents)
- Coexisting malignancy
- Serum creatinine>2.0 mg/dL
- AST or ALT >twice the upper limit of normal
- Hematocrit <32%
- TSH <0.4 or >5.5 mIU/L
- Intervention-specific exclusion criteria:
- Cold pressor stress test: history of Raynaud's disease
- High-fat challenge: malabsorption disorders, lactose intolerance, symptoms of gallbladder disease, and/or history of pancreatitis
- Dietary salt intervention: stage III or greater congestive heart failure and/or allergies to foods in the diet
- Aspirin intervention: history of bleeding disorder, gastrointestinal bleeding, blood pressure at the time of screening >160/95 mm Hg, current use of aspirin for a condition that would place the subject at increased risk if it were to be discontinued for 14 days before protocol initiation (eg, history of unstable angina, myocardial infarction, angioplasty, coronary artery bypass grafting, atrial fibrillation, stroke or transient ischemic attack, type 2 diabetes, or deep vein thrombosis/other thrombosis), polycythemia (hematocrit >52%), thrombocytosis (platelet count > 500 000), thrombocytopenia (platelet count <75 000), surgery within the last 6 months, aspirin allergy, current breastfeeding, and/or aggregation with collagen 5 μg/mL <6.65 Ω or >26 Ω or no aggregation at baseline with arachidonic acid
Who cannot join
None listed.
About this study
Official title: Genetic and Functional Analyses of Chromosome 1 Hypertension Susceptibility
High blood pressure affects nearly one third of all individuals in the United States. It is believed that genetic factors may predispose some people to develop this disease. This study will identify and characterize variations in three genes known to play a part in the development of high blood pressure.
Read the detailed description
High blood pressure is one of the most common health problems in this country. It can be caused by many factors, including stress, diet, diabetes, kidney disease, or obesity. In many people, there is no identifiable cause for their high blood pressure. If high blood pressure goes untreated, it can lead to heart failure, kidney failure, or stroke. Previous studies have shown that variations in three genes in chromosome 1-ATP1B1, RGS5, and SELE-cause some people to be more susceptible to developing high blood pressure. All three of these genes are involved in the development of proteins that play a role in regulating blood pressure, but it is not known exactly how variations in these genes affect blood pressure levels. This study will examine previously collected genetic samples from participants in two studies, the GenNet study and the Heredity and Phenotype Interaction (HAPI) Heart study. Study researchers will analyze the samples to identify and characterize variations in the ATP1B1, RGS5, and SELE genes. Results from this study may lead to more effective diagnostic and treatment options for people with high blood pressure.
- Conditions
- Hypertension
- Keywords
- Essential Hypertension, High Blood Pressure
- Medical subject headings
- Hypertension, Essential Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startAug 2003
- Primary completionJul 2006
- Study completionJul 2011
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 Maryland, BaltimoreThe 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
- Retrospective
- Enrolment
- 868 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Yen-Pei Christy Chang, University of Maryland, Baltimore
- Investigators
- Yen Pei C. Chang, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522119
- Sponsor's protocol ID
- 1403
- Other IDs
- R01HL088120
- Status last verified
- Aug 2019
- First submitted
- 27 Aug 2007
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Functional Analyses of Chromosome 1 Hypertension Susceptibility
- ClinicalTrials.gov ID
- NCT00522119
- Acronym / sponsor ID
- 1403
- Conditions
- Hypertension
- Keywords
- Essential Hypertension, High Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 868 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2003 (actual)
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Aug 2007 (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.
High blood pressure affects nearly one third of all individuals in the United States. It is believed that genetic factors may predispose some people to develop this disease. This study will identify and characterize variations in three genes known to play a part in the development of high blood pressure.
Detailed description
High blood pressure is one of the most common health problems in this country. It can be caused by many factors, including stress, diet, diabetes, kidney disease, or obesity. In many people, there is no identifiable cause for their high blood pressure. If high blood pressure goes untreated, it can lead to heart failure, kidney failure, or stroke. Previous studies have shown that variations in three genes in chromosome 1-ATP1B1, RGS5, and SELE-cause some people to be more susceptible to developing high blood pressure. All three of these genes are involved in the development of proteins that play a role in regulating blood pressure, but it is not known exactly how variations in these genes affect blood pressure levels. This study will examine previously collected genetic samples from participants in two studies, the GenNet study and the Heredity and Phenotype Interaction (HAPI) Heart study. Study researchers will analyze the samples to identify and characterize variations in the ATP1B1, RGS5, and SELE genes. Results from this study may lead to more effective diagnostic and treatment options for people with high blood pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Characteristic Men (n = 460) Women (n = 408) Age (y) 42.2 ± 0.6 45.4 ± 0.7 BMI (kg/m2) 25.6 ± 0.1 27.8 ± 0.3 TCHOL (mg/dL) 202.5 ± 2.1 215.7 ± 2.5 HDL (mg/dL) 52.6 ± 0.6 59.5 ± 0.8 TG (mg/dL) 63.9 ± 1.7 73.8 ± 2.3 SBP (mm Hg) 121.5 ± 0.6 121.4 ± 0.8 DBP (mm Hg) 77.6 ± 0.4 75.8 ± 0.4 Diabetes (%) 0.9 1.0 Current smokers (%) 20.0 0.0 * on lipid-lowering medications 1.1 1.0 * on antihypertensive medications 0.2 0.3
Key inclusion criteria (17 listed)
- Amish individuals from the Lancaster community in PA.
- Age< 20 yrs
- Non-Amish descent
- Currently pregnant or postpartum <6 m
- Blood pressure at the time of screening >180/105 (SBB/DBP) mm Hg
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 21 Aug 2019.
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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.
Yen Pei C. Chang, PhD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by University of Maryland, Baltimore.
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 17 inclusion and 0 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 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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 21 Aug 2019.