Dementia, cognitive decline, hypertension Nervous System Diseases
Conditions
Interventions
The study is a two-arm, randomized controlled clinical trial using a prospective, open-label, blinded endpoint (PROBE) design. The study is conducted in China.
Participants with newly diagnosed hype
Sponsors
First Affiliated Hospital of Shantou University Medical College
Shantou University Medical College
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Individuals aged 65–80 years 2. Not currently on AHM 3. Willing to receive regular (ATC-listed) antihypertensive treatment 4. Current mean SBP =140 and/or DBP =90 mmHg 5. Who are either: 5.1. Newly diagnosed with primary hypertension 5.2. Previously diagnosed but never treated; or 5.3. Previously treated but stopped AHM >3 years before baseline
Exclusion criteria
Exclusion criteria: 1. Current use of AHM 2. Dementia or relevant cognitive decline (defined as MMSE < 24 points; or < 21 points for ISCED level 1) 3. Contra-indications to use of an ARB or an ACEi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical diagnosis of all-cause dementia at any time during the study and/or clinically meaningful cognitive decline measured using >3-point decrease on the Mini Mental State Examination (MMSE) versus baseline at baseline, 1, 3 and 5 and five years | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause dementia measured using data collection on the clinical diagnosis made at any time during the study;Cognitive decline measured using >3-point decrease on the MMSE versus baseline at baseline, 1, 3 and 5 and five years;Incident cardiovascular events (myocardial infarction and stroke) measured using self-report at study assessments via electronic CRF, and using primary care records, hospital records, and/or death registry at any time during the study;Cardiovascular and all-cause death measured using primary care records, hospital records, and/or death registry at any time during the study;Changes in daily functioning from baseline measured using the Lawton Instrumental activity of daily living scale at baseline and daily at any time during the study | — |
Countries
China
Contacts
Public ContactEdo;Eric Richard;Moll van Charante
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Outcome results
None listed