Home Blood Pressure Intervention in the Community Trial

Обзор

The primary purpose of the study is to explore whether a lower home blood pressure target (125/75 v.s. 135/85 mmHg) would be beneficial to elderly treated hypertensive patients in terms of reduced incidence of cardiovascular events. The study also aims to promote the application of standardised and information-based home blood pressure monitoring in community hypertension management.

Вмешательства

• Препарат Intensive Home BP control
  If the target home BP level is not achieved during the follow-up periods, type and dosage of antihypertensive drugs will be adjusted according to current guidelines and physician's clinical experience.
• Препарат Standard Home BP control
  If the target home BP level is not achieved during the follow-up periods, type and dosage of antihypertensive drugs will be adjusted according to current guidelines and physician's clinical experience.

Первичные конечные точки

• Composite of adverse cardiovascular events [Срок оценки: 48 months]

Вторичные конечные точки (3)

• Components of the primary outcome [Срок оценки: 48 months]
• Renal outcome [Срок оценки: 48 months]
• Adverse or severe adverse events [Срок оценки: 48 months]

Критерии участия

Критерии включения

• Aged 60-80 years old
• Have been taking antihypertensive drugs for more than 2 weeks
• The average SBP and/or DBP of 7-day home blood pressure monitoring ≥135/85 mmHg
• Willing to participate, adhere to follow-up, and sign the written informed consent form

Критерии исключения

• Arm circumference too large or too small (less than 18 cm or greater than 42 cm) to fit the cuff in case of inaccurate measurement
• Invalid home blood pressure monitoring. The valid home blood pressure monitoring requires consecutive measurements for at least 3 days, with not less than 1 measurement in the morning and evening, respectively.
• Office blood pressure indicates stage 3 clinic hypertension (≥180/110 mmHg) during the screening period
• Suspected or known secondary hypertension
• Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than 20 mmHg or diastolic blood pressure greater than 10 mmHg within 3 minutes when position is changed from sitting to standing
• eGFR<30 ml/min/1.73m2 or end-stage renal disease
• Cardiovascular events occured within the past 3 months, such as myocardial infarction, stroke, acute heart failure, hospitalization for unstable angina, undergoing coronary artery revascularization or bypass grafting
• Abnormal liver function (ALT/AST/total bilirubin more than 2 times the upper limit of normal value)
• Severe somatic disease with a life expectancy of less than 3 years, or diagnosed with cancer within the past 2 years requiring treatment
• Doctors deem that the participation would do harm to the patients or the patients would have poor compliance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Community hospitals — Шанхай

Публикации

• Zhang DY, Zhang YQ, An DW, Cheng YB, Tang ST, Liu M, Li J, Staessen JA, Wang JG, Li Y; HomeBP Trial Investigators. A randomised trial comparing usual versus strict home blood pressure control in elderly patients with hypertension: protocol and initial progress. Blood Press. 2025 Dec;34(1):2472192. doi: 10.1080/08037051.2025.2472192. Epub 2025 Mar 2. PMID 39993302

Идентификаторы

NCT: NCT05858944 · 1.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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