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Effect of home blood pressure and office blood pressure target value monitoring on the outcome of cardiovascular disease in hypertensive patients

Effect of home blood pressure and office blood pressure target value monitoring on the outcome of cardiovascular disease in hypertensive patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084405
Enrollment
Unknown
Registered
2024-05-16
Start date
2024-05-20
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension

Interventions

home blood pressure monitoring group:Using home blood pressure monitoring as the basis for antihypertensive treatment and management
office blood pressure monitoring group:Using office blood pressure monitoring as the basis for antihypertensive treatment and management

Sponsors

Army Medical Center of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age is greater than 50 years old and less than or equal to 79 years old; 2.In the absence of medication, systolic blood pressure measured in the clinic on three different days is between 140-180mmHg, or patients with hypertension who are currently undergoing antihypertensive treatment; 3.At least one high-risk cardiovascular factor is met: 1)Clinical or subclinical cardiovascular and cerebrovascular diseases exist; (Clinical cardiovascular diseases include, but are not limited to: a) Previous (greater than 6 months) myocardial infarction (MI), stroke (including ischemic stroke and hemorrhagic stroke, excluding lacunar infarction and TIA), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), carotid endarterectomy (CE), carotid stent implantation; b) Previous (greater than 6 months) peripheral arterial disease (PAD) with revascularization; c) Previous (greater than 6 months) acute coronary syndrome, with or without resting ECG changes, ECG changes during exercise testing, or positive cardiac imaging studies; d) Coronary artery, carotid artery, or lower limb artery with at least 50% diameter stenosis; e) Abdominal aortic aneurysm (AAA) =5 cm, regardless of whether surgical treatment is performed. Subclinical diseases include: a) Coronary artery calcium scoring (Agatston units) =400 within the past 2 years; b) Ankle-brachial index (ABI) =0.90 within the past 2 years; c) ECG, echocardiography, or other cardiac imaging reports showing left ventricular hypertrophy (LVH) within the past 2 years.) 2)Chronic kidney disease (CKD), with an eGFR value of 30-59 ml/min/1.73m² based on the most recent laboratory test within the past 6 months. The eGFR is calculated according to the MDRD equation: eGFR (ml/min/1.73m²) = 186 × (Scr)^-1.154 × (Age)^-0.203 × (0.742 if female) × 1.233 (J Am Soc Nephrol. 2006;17:2937-44). 3)Comorbid with type 2 diabetes, with fasting blood glucose greater than or equal to 7.0mmol/L and/or glycated hemoglobin (=6.5%) as the diagnostic criteria for diabetes. 4)According to the results of the most recent lipid laboratory test within the past 12 months, the 10-year cardiovascular disease risk assessed by the China-PAR risk assessment model is =10%. 5)Age is =70 years old. 4.An informed consent form has been obtained and signed.

Exclusion criteria

Exclusion criteria: (1) SBP is =180mmHg and/or DBP is 2.5mg/dL [>221µmol/L]; (14) Symptomatic heart failure or reduced left ventricular ejection fraction (<40%) within the past 6 months; (15) History of atrial fibrillation; (16) Hypotensive events or symptoms such as dizziness and fatigue caused by blood pressure reduction to SBP =130mmHg (office blood pressure) during previous antihypertensive treatment, and cannot tolerate continued blood pressure reduction treatment. (17) History of allergy to medication or its components in the study; (18) Currently participating in other clinical studies; (19) Patients with disabilities, mobility impairments, intellectual disabilities, and other factors that may prevent normal participation in the study and follow-up (if necessary, assess frailty using the FRAIL scale, and assess cognitive mental state using the MMSE scale); (20) There are situations that may affect patient compliance, or the researcher believes there are other reasons that are not suitable for clinical trials. (a) History of alcohol or drug abuse within the past 12 months. (b) Planning to move away from the follow-up site within 2 years (short term) and unable to transfer to another HAO-Target follow-up site. (c) Patients with a history of not complying with medical advice or follow-up. (d) Significant concerns from the spouse, significant other, or family member about participating in the study. (e) Clinical diagnosis of dementia, and receiving medication for dementia, or the researcher judges that the subject is cognitively unable to follow the trial process. (21) Clinically diagnosed patients with high anxiety.

Design outcomes

Primary

MeasureTime frame
non-fatal stroke;non-fatal myocardial infarction;acute heart failure;Coronary Artery Revascularization;death attributable to cardiovascular disease;

Secondary

MeasureTime frame
new-onset atrial fibrillation;new-onset diabetes mellitus;Declined renal function or progression to end-stage renal disease.;Declined cognitive function or dementia;All-cause mortality;Non-MI ACS;hospitalized for TIA;

Countries

China

Contacts

Public ContactZeng Chunyu

Army Medical Center of PLA

chunyuzeng01@163.com+86 139 8362 4369

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026