此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Prevalence of Resistant Hypertension With DOT (DOT)

2019年3月19日 更新者:Ottawa Hospital Research Institute

The Prevalence of Pseudo-resistant Hypertension Using the Direct Observed Therapy Test: A Prospective Observational Study

High blood pressure is a risk factor for bad clinical events, such as heart failure, stroke, kidney failure and death. This risk is much higher in those with 'resistant' hypertension, in whom the blood pressure remains high despite more than 3 blood pressure medicines. Current estimates of the proportion of individuals with resistant hypertension may be an overestimate, since some of them are not actually adherent (i.e. not taking the medicines they are prescribed). Methods to detect non-adherence, such as asking the patient, counting pills, and getting records from pharmacy are not fool proof. Direct observed therapy (where patients are administered medicines under observation by a health care personnel) is quite useful to diagnose this, and is the standard of care in the Renal Hypertension Clinic, before more tests and interventions (such as CT scans, renal angiogram) are performed.

In this study, the investigators will measure the proportion of patients with resistant hypertension who are non-adherent based on direct observed therapy, and follow them up to examine the impact of this diagnosis.

研究概览

地位

完全的

条件

详细说明

This is a prospective, observational study.

Patients fitting inclusion and exclusion criteria, after informed consent, will undergo the direct observed therapy test in the hypertension unit (this is usual care in the unit, which they will undergo even if they are not part of the study).

The Direct Observation Therapy (DOT) Test includes the following components:

  1. Administer and observe ingestion of usual morning antihypertensive medications.
  2. Monitor BP every 30 minutes, using 5 readings of an automated oscillometric BP device ( BP-TRU), until plateau affect achieved, defined as 3 consecutive cycles of BP readings declining by less than 10 mmHg per cycle).
  3. Registered Nurse (RN) repeats standing BP prior to initiation of 24 hour Ambulatory Blood Pressure Monitoring(ABPM).
  4. RN initiates 24 hour ABPM

In addition, participants will undergo an additional 24-hour ABPM test 1 month after the DOT test is undertaken.

研究类型

观察性的

注册 (实际的)

60

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

    • Ontario
      • Ottawa、Ontario、加拿大、K1H7W9
        • Ottawa Hospital Research Institute

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

取样方法

非概率样本

研究人群

The study population is patients with resistant hypertension referred to a tertiary care hypertension clinic.

描述

Inclusion Criteria:

  1. Age 18 years or older
  2. Confirmed resistant hypertension defined as daytime BP readings above 135/85 mmHg (confirmed by 24-hour ABPM results) using 3 or more BP lowering drugs
  3. Adherence to medications confirmed by patient, and by hypertension clinic on basis of pharmacy filling record

Exclusion Criteria:

  1. Pregnant patients
  2. Inability to provide informed consent

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

队列和干预

团体/队列
干预/治疗
Direct Observed Therapy test
Patients with resistant hypertension (as defined in the eligibility criteria) will be enrolled. They will all have undergone 24 hour ambulatory blood pressure monitoring (ABPM) before enrollment. As part of the study, the subjects will undergo direct observed therapy testing, followed by another 24 hour ABPM, which will be repeated at 1 month.
There is one group only, all of whom will undergo direct observed therapy testing

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
Prevalence of true resistant hypertension
大体时间:1 week
The proportion of patients who continue to have resistant hypertension after administration of direct observed therapy, on the basis of the 24 hour ambulatory testing
1 week

次要结果测量

结果测量
措施说明
大体时间
Prevalence of resistant hypertension at 1 month
大体时间:1 month
The proportion of patients who continue to have resistant hypertension at one month, on the basis of the 24 hour ambulatory testing
1 month

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:Marcel Ruzicka, MD PhD、Ottawa Hospital Research Institute

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9月1日

初级完成 (实际的)

2018年7月1日

研究完成 (实际的)

2018年9月1日

研究注册日期

首次提交

2015年7月23日

首先提交符合 QC 标准的

2015年7月29日

首次发布 (估计)

2015年7月31日

研究记录更新

最后更新发布 (实际的)

2019年3月21日

上次提交的符合 QC 标准的更新

2019年3月19日

最后验证

2019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

  • 4096

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.

订阅