Prevalence of Resistant Hypertension With DOT (DOT)
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
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:
- Administer and observe ingestion of usual morning antihypertensive medications.
- 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).
- Registered Nurse (RN) repeats standing BP prior to initiation of 24 hour Ambulatory Blood Pressure Monitoring(ABPM).
- 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
注册 (实际的)
联系人和位置
学习地点
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Ontario
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Ottawa、Ontario、加拿大、K1H7W9
- Ottawa Hospital Research Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age 18 years or older
- 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
- Adherence to medications confirmed by patient, and by hypertension clinic on basis of pharmacy filling record
Exclusion Criteria:
- Pregnant patients
- Inability to provide informed consent
学习计划
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 |
|---|---|
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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.
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There is one group only, all of whom will undergo direct observed therapy testing
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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 |
|---|---|---|
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Prevalence of true resistant hypertension
大体时间:1 week
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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
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1 week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Prevalence of resistant hypertension at 1 month
大体时间:1 month
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The proportion of patients who continue to have resistant hypertension at one month, on the basis of the 24 hour ambulatory testing
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1 month
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合作者和调查者
调查人员
- 首席研究员:Marcel Ruzicka, MD PhD、Ottawa Hospital Research Institute
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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