HypertensionNCT00260910
Progression Evaluation and Genetic Determinants of Hypertension in Chinese - A Follow-up Study of Taiwan SAPPHIRe
An observational study of Hypertension, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine the progression evaluation and genetic determinations of hypertension in Chinese Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 1,246 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2001to Dec 2005
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A follow-up genetic study of Taiwan SAPPHIRe Cohort
Who may be able to join
- Age of subjects when recruited must be between 35 and 60 years. Subjects over age 60 may also be eligible provided that documentation of their hypertension status prior to age 60 is available.
- Chinese ancestry, i.e. all four grandparents Chinese. Hypertension is defined as follows: systolic BP (SBP) greater than or equal to (>=) 160 mm Hg or diastolic BP (DBP) >= 95 mm Hg or taking 2 medications for high blood pressure (Stage II hypertension). Alternatively the subject could have uncontrolled hypertension, i.e. taking 1 medication for high blood pressure and has either systolic BP >= 140 or diastolic >= 90 mm Hg.
Who cannot join
- One of the affected sibs is adopted (i.e. no parent in common) or if the sibs have only one parent in common.
- Both parents have been treated for hypertension before the age of 60. If offspring reports about their parents' hypertension status are conflicting, then a single reliable report of hypertension in both parents before age 60 is cause for exclusion. This exclusion criterion, however, does not apply to discordant sib-pairs.
- Diabetic individuals were excluded. Diabetes uncovered as a result of SAPPHIRe lab work does not lead to exclusion however.
- Severe kidney disease (except stones and remote infections) of creatinine > 1.5 mg/dl, unless documented proof that the subject met inclusion criteria prior to increase in creatinine levels.
- A body-mass index greater than 35.
- In addition, the following conditions are considered as cause for exclusion: ongoing (or within the past 6 months) treatment for cancer; terminal illness (life expectancy fewer than 6 months); liver cirrhosis or any other chronic illness; pregnancy or fewer than 6 months post-partum.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the progression evaluation and genetic determinations of hypertension in Chinese
Read the detailed description
Blood pressure is a quantitative trait affected by both genetic and environmental factors. It is known that human essential hypertension does not follow a simple Mendelian mode of inheritance. Stanford-Asian Pacific Program in Hypertension and Insulin Resistance (SAPPHIRe) is an international genetic study, which intends to map the major genetic loci underlying hypertension in sibpairs of Asian-Pacific Chinese and Japanese origin. Based on the data generated through year 1 to year 5, preliminary analysis has not shown positive results in the linkage analysis of genome wide scan data, although association studies of some candidate genes give promising results.
Success in genetic studies may depend on many factors including the selection of the patient population, the identification of intermediate phenotypes, the disease subsets, and the genetic strategy and methodologies employed. According to our previous analysis, presented in SAPPHIRe Steering Committee meetings (twice a year), there is heterogeneity among Chinese and Japanese origins.
In order to reduce heterogeneity of the genetic and environmental background, we will focus our investigation on the Chinese population. Furthermore, besides the variables associated with insulin resistance, which were collected and studied in year 1 through 5 of SAPPHIRe, some more variables will be collected and studied in order to identify most sensible intermediate phenotypes and more homogeneous disease subsets.
Our general approach is to continue analyzing candidate genes as well as perform a complete genome search based on the exiting genome-wide scan data together with old and new phenotype variables.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startMay 2001
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 1,246 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Tri-Service General Hospital (TSGH), Taipei Veterans General Hospital, Taiwan, Taichung Veterans General Hospital
- Responsible party
- Sponsor
- Investigators
- Chao Hsiung, PhD, Study director, Division of Biostatistics and Bioinformatics, National Health Research Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260910
- Sponsor's protocol ID
- EC9003003
- Status last verified
- Aug 2009
- First submitted
- 1 Dec 2005
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lee IT, Chiu YF, Hwu CM, He CT, Chiang FT, Lin YC, Assimes T, Curb JD, Sheu WH. Central obesity is important but not essential component of the metabolic syndrome for predicting diabetes mellitus in a hypertensive family-based cohort. Results from the Stanford Asia-pacific program for hypertension and insulin resistance (SAPPHIRe) Taiwan follow-up study. Cardiovasc Diabetol. 2012 Apr 26;11:43. doi: 10.1186/1475-2840-11-43.
PubMed 22537054
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression Evaluation and Genetic Determinants of Hypertension in Chinese - A Follow-up Study of Taiwan SAPPHIRe
- ClinicalTrials.gov ID
- NCT00260910
- Acronym / sponsor ID
- EC9003003
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,246 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Tri-Service General Hospital (TSGH), Taipei Veterans General Hospital, Taiwan, Taichung Veterans General Hospital
- Study start
- May 2001
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 2 Dec 2005 (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.
The purpose of this study is to determine the progression evaluation and genetic determinations of hypertension in Chinese
Detailed description
Blood pressure is a quantitative trait affected by both genetic and environmental factors. It is known that human essential hypertension does not follow a simple Mendelian mode of inheritance. Stanford-Asian Pacific Program in Hypertension and Insulin Resistance (SAPPHIRe) is an international genetic study, which intends to map the major genetic loci underlying hypertension in sibpairs of Asian-Pacific Chinese and Japanese origin. Based on the data generated through year 1 to year 5, preliminary analysis has not shown positive results in the linkage analysis of genome wide scan data, although association studies of some candidate genes give promising results.
Success in genetic studies may depend on many factors including the selection of the patient population, the identification of intermediate phenotypes, the disease subsets, and the genetic strategy and methodologies employed. According to our previous analysis, presented in SAPPHIRe Steering Committee meetings (twice a year), there is heterogeneity among Chinese and Japanese origins.
In order to reduce heterogeneity of the genetic and environmental background, we will focus our investigation on the Chinese population. Furthermore, besides the variables associated with insulin resistance, which were collected and studied in year 1 through 5 of SAPPHIRe, some more variables will be collected and studied in order to identify most sensible intermediate phenotypes and more homogeneous disease subsets.
Our general approach is to continue analyzing candidate genes as well as perform a complete genome search based on the exiting genome-wide scan data together with old and new phenotype variables.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A follow-up genetic study of Taiwan SAPPHIRe Cohort
Key inclusion criteria (2 listed)
- Age of subjects when recruited must be between 35 and 60 years. Subjects over age 60 may also be eligible provided that documentation of their hypertension status prior to age 60 is available.
- Chinese ancestry, i.e. all four grandparents Chinese. Hypertension is defined as follows: systolic BP (SBP) greater than or equal to (>=) 160 mm Hg or diastolic BP (DBP) >= 95 mm Hg or taking 2 medications for high blood pressure (Stage II hypertension). Alternatively the subject could have uncontrolled hypertension, i.e. taking 1 medication for high blood pressure and has either systolic BP >= 140 or diastolic >= 90 mm Hg.
Key exclusion criteria (6 listed)
- One of the affected sibs is adopted (i.e. no parent in common) or if the sibs have only one parent in common.
- Both parents have been treated for hypertension before the age of 60. If offspring reports about their parents' hypertension status are conflicting, then a single reliable report of hypertension in both parents before age 60 is cause for exclusion. This exclusion criterion, however, does not apply to discordant sib-pairs.
- Diabetic individuals were excluded. Diabetes uncovered as a result of SAPPHIRe lab work does not lead to exclusion however.
- Severe kidney disease (except stones and remote infections) of creatinine > 1.5 mg/dl, unless documented proof that the subject met inclusion criteria prior to increase in creatinine levels.
- A body-mass index greater than 35.
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 7 Apr 2016.
- Derived from this study: PubMed 22537054Lee IT, Chiu YF, Hwu CM, He CT, Chiang FT, Lin YC, Assimes T, Curb JD, Sheu WH. Central obesity is important but not essential component of the metabolic syndrome for predicting diabetes mellitus in a hypertensive family-based cohort. Results from the Stanford Asia-pacific program for hypertension and insulin resistance (SAPPHIRe) Taiwan follow-up study. Cardiovasc Diabetol. 2012 Apr 26;11:43. doi: 10.1186/1475-2840-11-43.
- Individual participant dataSharing planned: Undecided
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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.
Chao Hsiung, PhD study director
Division of Biostatistics and Bioinformatics, National Health Research Institutes
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 National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 6 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 7 Apr 2016. 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 Taiwan. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260910, which also lists 1 linked publication.
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 7 Apr 2016.