Predisposition and Transition Mechanisms From Arterial Hypertension to Heart Failure (Hypercare)
2015年4月27日 更新者:Central Hospital, Nancy, France
Genetics and Genomics of Hypertension Associated With Microinflammation, Oxydative Stress, Chronic Renal Disease and Heart Failure (A2-B2-B3)
This project aims at investigating the genetic, genomic and proteomic basis of hypertension and susceptibility to hypertension-related end organ damage (renal damage and heart failure).
It will include cross sectional as well as follow-up studies with a large number of subjects and variety of phenotypes, to explore the pathophysiology of hypertension and hypertension-related disease.
研究概览
详细说明
In all index patients and recruited family members, recorded data will include the following :
- Past medical history, drug history and family history
- Physical examination
- Height, weight, waist and hip circumference
- Cardiac examination
- Vascular examination
- Blood pressure
- Plasma and urine samples
- Body composition (DEXA)
- Tissue Doppler imaging
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Alsace
-
Strasbourg、Alsace、法国、67000
- Centre D'Investigation Clinique de Strasbourg
-
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Lorraine
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Nancy、Lorraine、法国、54000
- Hopital Brabois Adulte
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
index patient :
- Caucasian patients of either sex who were diagnosed to have essential hypertension (as defined below) before the age of 50 y.
- The index patient should not be older than 60 years at the time of enrolment.
Definition of hypertension for the index patient:
- If untreated: Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 95 mmHg.
- If already on treatment: Treatment with more of 2 different antihypertensive drugs at the time of enrolment.
- At least three first degree relatives of whom at least one should be affected and at least one be from a different generation (parents or offspring aged 18 years or above) must be willing to participate in the family study. For definition of hypertension in relatives of the index patient see below.
- Written informed consent
family
- at least three other first degree relatives must be willing to participate in the family study:
- at least one first-degree relative must be affected with diagnosis of hypertension made before age of 50 years AND
- at least one first degree relative must be from a different generation (offspring or parents).
Exclusion Criteria:
index patient :
- Any known form of secondary hypertension, including sleep apnoea syndrome
- Any known previous clinical complications of hypertension (angina, MI, stroke, TIA, peripheral artery disease) at any time
- Any known renal disease, including GFR < 60 mL/min as estimated by the abbreviated MDRD formula, or kidney stones
- Kidney or other organ transplantation
- Type 1 diabetes mellitus
- Heart failure stage D (AHA/ACC criteria)
- Any malignant concomitant diseases or history of malignant diseases within the last five years, with exception of treated squamous skin cancer or basalioma
- Clinical or laboratory signs of acute infection, especially urinary tract infection
- Systemic inflammatory diseases, such as autoimmune diseases, connective tissue diseases or collagenoses.
- Steroids or any other immunosuppressive drug
- Severe known liver disease (ALT or gamma-GT above three-fold of upper normal limit)
- Current alcohol consume of more than 21 drinks/week (1 drink = a bottle (0,33 l) beer, a glass (0,2 l) of wine, or 4 cl = 40 ml of spirit (40%)) or drug abuse such as cocaine
family
- any organ transplantation
- any malignant concomitant disease
- acute infection
- systemic inflammatory disease
- severe liver disease
- current alcohol or drug abuse
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:NOE
multicentric family-based cohort.
prospective and transversal study
|
blood and urine sample
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
genetic biomarkers
大体时间:time point 1 : first day ; Time point
|
time point 1 : first day ; Time point
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
oxidative stress markers
大体时间:time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
|
time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
|
|
microinflammation markers
大体时间:time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
|
time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
|
|
renal function and damage markers
大体时间:time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
|
time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
|
|
cardiac and large artery growth, remodelling dysfunction and failure markers
大体时间:time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
|
time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:faiez ZANNAD, Pr、Central Hospital, Nancy, France
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年11月1日
初级完成 (实际的)
2015年2月1日
研究完成 (实际的)
2015年2月1日
研究注册日期
首次提交
2010年2月5日
首先提交符合 QC 标准的
2015年4月27日
首次发布 (估计)
2015年4月30日
研究记录更新
最后更新发布 (估计)
2015年4月30日
上次提交的符合 QC 标准的更新
2015年4月27日
最后验证
2010年2月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- HYPERCARE(english v. 1.0)JRPB3
- Cpp : 07.11.11
- Dgs: 2007-0537
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.