Home Blood Pressure Intervention in the Community Trial

Home Blood Pressure Clinical Trial

Official title:

Home Blood Pressure Intervention in the Community Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858944
• Other study ID #: 1.1
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2023
• Source: Shanghai Institute of Hypertension
• Contact: Yan Li, Professor
• Phone: +8613482234463
• Email: liyanshcn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Home Blood Pressure

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Community hospitals	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Hypertension

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of adverse cardiovascular events	Composite of major adverse cardiovascular events consisting of death from cardiovascular diseases, non-fatal stroke, myocardial infarction, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), hospitalization for heart failure or unstable agina.	48 months
Secondary	Components of the primary outcome	Occurrence of any components of the primary outcome (death from cardiovascular diseases, non-fatal stroke, myocardial infarction, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), hospitalization for heart failure or unstable agina).	48 months
Secondary	Renal outcome	Including end stage renal disease (ESRD) and a decrease in the eGFR of 30% or more	48 months
Secondary	Adverse or severe adverse events	Especially dizziness and falls caused by hypotension, and orthostatic hypotension	48 months