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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ontario
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Ottawa, Ontario, 캐나다, K1H7W9
- Ottawa Hospital Research Institute
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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 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prevalence of true resistant hypertension
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prevalence of resistant hypertension at 1 month
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Marcel Ruzicka, MD PhD, Ottawa Hospital Research Institute
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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