Dementia, cognitive decline, hypertension
Conditions
Interventions
Angiotensin II receptor blocker group:Use angiotensin II receptor blockers to lower blood pressure step by step
Angiotensin-converting enzyme inhibitor group:Use angiotensin-converting enzyme inhibitors to lower blood pressure in steps
Sponsors
The First Affiliated Hospital of Shan Tou University Medical College
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects meeting the study inclusion criteria are those aged 65 to 80 years, who are willing to receive standard antihypertensive drug therapy (using drugs listed in the WHO ATC classification system) and who meet any of the following criteria: 1. Have newly diagnosed hypertension, defined as: average systolic blood pressure (SBP) >=140 mmHg and/or diastolic blood pressure (DBP) >=90 mmHg from 3 measurements at the screening visit, confirmed by repeat 3 measurements at the baseline visit, and currently not using antihypertensive medication (AHM); 2. Have a previous diagnosis of hypertension but have never used AHM, and have an average SBP >=140 mmHg and/or DBP >=90 mmHg from 3 measurements at the screening visit, confirmed by repeat 3 measurements at the baseline visit; 3. Have a previous diagnosis of hypertension and have used AHM, but have discontinued medication for more than 3 years before the baseline visit, and currently have an average SBP >=140 mmHg and/or DBP >=90 mmHg from 3 measurements at the screening visit, confirmed by repeat 3 measurements at the baseline visit. At each visit (screening/baseline), blood pressure is measured 3 times, with 5-minute intervals between each measurement. If the average SBP >=140 mmHg and/or DBP >=90 mmHg from the 3 measurements at the screening visit, the subject may proceed to the baseline visit (provided all other inclusion criteria are met); if the subject's blood pressure mean at the subsequent baseline visit meets SBP >=140 mmHg and/or DBP >=90 mmHg, the subject may be formally enrolled.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are excluded: current use of antihypertensive medication; existing dementia or significant cognitive decline (MMSE <24 points; or for those with an ISCED level <=1, i.e., primary education or no formal education, <21 points); or contraindications to ARB/ACEi. Prior diagnosis of cardiovascular disease and/or diabetes is not an exclusion criterion. Exclusion criteria include: current use of AHM; existing dementia or significant cognitive decline (defined as MMSE score <24 points; or ISCED level 0 or 1 score <21 points); or any contraindication to ARB and ACEi; however, prior diagnosis of CVD and/or diabetes is not an exclusion condition. These criteria are intended to ensure the recruitment of a representative heterogeneous population with untreated hypertension, so as to evaluate the specific effects of AHM on the risk of cognitive decline and dementia in a real-world hypertensive population. Patients with hyperuricemia are not excluded, as they will receive standard management according to the treatment protocol (see Chapter 5, "Subject Treatment"). The use of beta-blockers for non-antihypertensive indications (e.g., arrhythmias or migraine) is also not grounds for exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dementia from all causes (all-cause dementia) or clinically significant cognitive decline occurring since baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dementia and cognitive decline caused by all reasons (evaluated separately);Dementia and cognitive decline caused by all reasons (evaluated separately);Dementia and cognitive decline caused by all reasons (evaluated separately);Activities of daily living;The difference in MMSE score changes between the intervention group and the control group over time; | — |
Countries
China
Contacts
Public ContactChen Yequn
The First Affiliated Hospital of Shan Tou University Medical College
Outcome results
None listed