Trial record 5 of 9 for:    CARDIOVASCULAR SAPPHIRE

Progression Evaluation and Genetic Determinants of Hypertension in Chinese - A Follow-up Study of Taiwan SAPPHIRe

This study has been completed.
Sponsor:
Collaborators:
National Taiwan University Hospital
Tri-Service General Hospital
Taipei Veterans General Hospital, Taiwan
Taichung Veterans General Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00260910
First received: December 1, 2005
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

The purpose of this study is to determine the progression evaluation and genetic determinations of hypertension in Chinese


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Family-Based
Official Title: Progression Evaluation and Genetic Determinants of Hypertension in Chinese - A Follow-up Study of Taiwan SAPPHIRe

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Study Start Date: May 2001
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

A follow-up genetic study of Taiwan SAPPHIRe Cohort

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260910

Locations
Taiwan
Division of Biostatistics and Bioinformatics, NHRI
Miaoli county, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Tri-Service General Hospital
Taipei Veterans General Hospital, Taiwan
Taichung Veterans General Hospital
Investigators
Study Director: Chao Hsiung, PhD Division of Biostatistics and Bioinformatics, National Health Research Institutes
  More Information

No publications provided by National Health Research Institutes, Taiwan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00260910     History of Changes
Other Study ID Numbers: EC9003003
Study First Received: December 1, 2005
Last Updated: August 12, 2009
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014