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Relationship Between Genes Important in Blood Pressure Regulation and Blood Pressure Therapy in Hypertension

2017年3月18日 更新者:Geneticure, LLC

Assessment of the Relationship Between Genes That Encode Proteins Important in Blood Pressure Regulation and Blood Pressure Therapy in Patients With Hypertension

Whether patients with a functional genotype of a protein important in blood pressure regulation respond better to a drug therapy class/combination of therapy classes that target that specific pathway using the Geneticure panel for high blood pressure

研究概览

详细说明

2.1 Study Design and Protocol Overview This is a post-hoc association study of patients who have been diagnosed with high blood pressure and have been stable on medication treatment for at least 6 months. The purpose of this study is to evaluate the relationship between optimal medication therapy (or the therapy that has resulted in the most stable blood pressure for that particular patient) and the predicted optimal medication therapy based on a patient's genetic profile.

Chart reviews for the patient's history of antihypertensive therapy will be coupled with buccal swabs and blood pressure readings collected from eligible patients who have provided informed consent. The swab will be analyzed for fourteen genetic variants that are associated with antihypertensive therapy response (efficacy, side-effects).

2.2 Study Objective To assess the relationship between the drug therapy class/combination of therapy classes that resulted in the best blood pressure control for a patient vs. what the Geneticure high blood pressure panel would have predicted.

2.3 Secondary Objectives

  • To assess the clinical time to achieve optimal blood pressure treatment.
  • To assess the number of office visits required to achieve optimal blood pressure treatment.

研究类型

观察性的

注册 (实际的)

99

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

30年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with hypertension

描述

Inclusion Criteria:

  1. Subject is able and willing to provide informed consent
  2. Subject is ≥ 30 and ≤ 70 years of age
  3. Subject with diagnosis of Hypertension for a minimum of 1 year
  4. Subject has been on the same class/classes of blood pressure medication for a minimum of 6 months. Note: A change in dosage, frequency, or specific medication is acceptable as long as there have been no changes to the class/classes of medications prescribed.
  5. Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 35
  6. Subject is currently prescribed and taking one of the following classes of medications alone or in combination with each other or a Ca+ channel blocker.

    • Diuretics
    • ACE Inhibitors
    • Angiotensin Receptor Blocker (ARB)
    • Beta-blockers

Exclusion Criteria:

  1. Subject has clinically significant kidney disease as determined by the investigator.
  2. Subject has clinically significant cardiac disease as determined by the investigator.
  3. Subject has clinically significant vascular disease as determined by the investigator.
  4. Subject has a diagnosis of secondary hypertension or is experiencing a complication of pregnancy.
  5. Subject is currently prescribed and taking any additional class of medication(s) for high blood pressure not included in the list above, with the exception of a Ca+ channel blocker.
  6. Subject has Systolic BP > 190 or Diastolic BP > 120 documented within the six months prior to visit.
  7. Subject has a regular alcohol intake of greater than 21 units per week in the past 6 months
  8. Subject has smoked greater than two packs of cigarettes (total) or equivalent nicotine intake in the past 6 months.
  9. Subject has an anticipated survival less than 12 months.
  10. Any other reason that the subject is inappropriate for study enrollment in the opinion of the Investigator.

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Ambulatory blood pressure changes (using sphygmomanometry) in response to therapy according to genes important in blood pressure regulation
大体时间:one year
To assess the relationship between the drug therapy class/combination of therapy classes that resulted in the best blood pressure control for a patient vs. what the Geneticure high blood pressure panel would have predicted. We will assess blood pressure values (systolic and diastolic blood pressure, in mmHg) at rest in patients on different blood pressure medications.
one year

次要结果测量

结果测量
大体时间
The clinical time to achieve optimal blood pressure treatment
大体时间:One year
One year
The number of office visits required to achieve optimal blood pressure treatment.
大体时间:One year
One year

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

  • 研究主任:Krista Kleve、RCRI

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。

一般刊物

  • Johnson MW, Sprissler R, Olson TP, Beenken GW, Snyder EM. Multi-Gene Pharmacogenetics and Blood Pressure Control in Patients with Hypertension. The FASEB Journal 30:942.1. 2016
  • Johnson MW, Sprissler R, Olson TP, Beenken GW, Snyder EM. Time to Blood Pressure Control According to Drug Class in Patients with Hypertension. The FASEB Journal 30:941.12. 2016.

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

2015年4月1日

初级完成 (实际的)

2015年6月1日

研究完成 (实际的)

2015年6月1日

研究注册日期

首次提交

2015年8月10日

首先提交符合 QC 标准的

2015年8月14日

首次发布 (估计)

2015年8月17日

研究记录更新

最后更新发布 (实际的)

2017年3月21日

上次提交的符合 QC 标准的更新

2017年3月18日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GTC01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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