- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00260910
Progression Evaluation and Genetic Determinants of Hypertension in Chinese - A Follow-up Study of Taiwan SAPPHIRe
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Miaoli county, 대만
- Division of Biostatistics and Bioinformatics, NHRI
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Chao Hsiung, PhD, Division of Biostatistics and Bioinformatics, National Health Research Institutes
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .