HypertensionNCT00631956
SAPPHIRe III in Taiwan-Progression Evaluation and Cardiovascular Outcomes of Hypertensive Families
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, cardiovascular outcomes, and genetic determinations of hypertension in Chinese Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hypertension
- How many people
- 1,038 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2006to Dec 2016
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- 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.
Taiwan1 site
Division of Biostatistics and Bioinformatics, NHRI
Miaoli County, 350
About this study
Official title: Progression Evaluation and Cardiovascular Outcomes of Hypertensive Families-A Follow-up Genetic Study of Taiwan SAPPHIRe Cohort
The purpose of this study is to determine the progression evaluation, cardiovascular outcomes, and genetic determinations of hypertension in Chinese
Read the detailed description
Blood pressure is a quantitative trait affected by both genetic and environmental factors. 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.
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.
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 from echocardiographic examination and multi-detector row computed tomography (MDCT) will be collected and studied.
Hypertension is a major risk factor for stroke, myocardial infraction and renal disease. Hypertension often occurs in combination with other metabolic complications such as hyperlipidemia, obesity and insulin resistance. The combined disorder is often called the metabolic syndrome.
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. Our objective is to identify susceptible gene for hypertension through incorporating intermediate phenotypes and to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect cardiovascular disorder patients.
- 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 posted10 Mar 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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.
- 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
- 1,038 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
- NCT00631956
- Sponsor's protocol ID
- EC0950806
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2008
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 Cardiovascular Outcomes of Hypertensive Families-A Follow-up Genetic Study of Taiwan SAPPHIRe Cohort
- ClinicalTrials.gov ID
- NCT00631956
- Acronym / sponsor ID
- EC0950806
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,038 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
- Oct 2006
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Mar 2008 (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, cardiovascular outcomes, and genetic determinations of hypertension in Chinese
Detailed description
Blood pressure is a quantitative trait affected by both genetic and environmental factors. 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.
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.
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 from echocardiographic examination and multi-detector row computed tomography (MDCT) will be collected and studied.
Hypertension is a major risk factor for stroke, myocardial infraction and renal disease. Hypertension often occurs in combination with other metabolic complications such as hyperlipidemia, obesity and insulin resistance. The combined disorder is often called the metabolic syndrome.
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. Our objective is to identify susceptible gene for hypertension through incorporating intermediate phenotypes and to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect cardiovascular disorder patients.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- 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: status not confirmed, 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?
Results are not available in the source record.
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 7 Apr 2016.