No registrations found.
ID
Source
Brief title
Health condition
antihypertensive therapy - cognitive functioning - elderly
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the change in the compound cognitive score between baseline and follow-up at 4 months after randomisation (At baseline and at 4 months follow-up, from all patients a number of cognitive measurements will be obtained: MMSE, for global cognitive functioning, Stroop-Colour Word Test (SCWT) and Trail Making Test (TMT) for executive functioning, 15-Word Verbal Learing Test (15-WVLT) and Visual Association Test (VAT) for (immediate and delayed) verbal and picture memory, and Letter-Digit Substitution Test (LDST) for psychomotor speed. The six aforementioned cognitive tests will be combined in a cognitive compound score.
Secondary outcome
At baseline and at 4 months follow-up, moreover, the Neuropsychiatric Inventory (NPI) will be carried out for, among others, assessment of depression and apathy (Cummings et al., 1994). Furthermore, general daily functioning will be assessed with the Groningen Activity Restriction Scale (GARS) (Kempen et al., 1996) and quality of life with Cantril’s ladder (Cantril, 1965). Secondary outcome measures are the change in the four separate cognitive domains (global cognitive functioning, executive functioning, (immediate and delayed) memory and psychomotor speed; the change in depressive symptoms and apathy as assessed with the NPI; physical functioning as assessed with the GARS, and quality of life according to Cantril’s ladder.
Background summary
Blood pressure reduction in older people may lead to hypoperfusion, especially in patients with cerebral small vessel disease, resulting in increased mental health problems like cognitive impairment, depression, and apathy. In this study we will assess whether temporary discontinuation of antihypertensive therapy in mildly cognitively impaired older patients on antihypertensive treatment improves cognitive and psychological functioning.
Study objective
To assess whether temporary discontinuation of antihypertensive therapy in mildly cognitively impaired older patients on antihypertensive treatment improves cognitive and psychological functioning.
Study design
Baseline measurement and 4 months of follow-up.
Intervention
Patients will be randomized to either continuation (n=200) or discontinuation (n=200) of antihypertensive treatment. Discontinuation of antihypertensive medication by patients’ own general practitioner may vary from abrupt and complete discontinuation to gradual and partial discontinuation, with a 20 mmgHg increase in systolic blood pressure as target and 180 mmHg as maximum systolic blood pressure.
Leiden University Medical Center<br>
PO Box 9600
R.C. Mast, van der
Leiden 2300 RC
The Netherlands
+31 (0)71 5263785
r.c.van_der_mast@lumc.nl
Leiden University Medical Center<br>
PO Box 9600
R.C. Mast, van der
Leiden 2300 RC
The Netherlands
+31 (0)71 5263785
r.c.van_der_mast@lumc.nl
Inclusion criteria
1. Age ≥ 75 years;
2. Current antihypertensive treatment;
3. Current systolic blood pressure < 160 mmHg;
4. Mini-Mental State Examination (MMSE) score ≥ 21 and ≤ 27.
Exclusion criteria
1. A history of myocardial infarction, stroke, coronary reperfusion procedures (CABG/PCI) < 3 years;
2. Heart failure requiring antihypertensive medication.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2300 |
| NTR-old | NTR2829 |
| Other | METC LUMC / ZonMw : P10.208 / 40-41600-98-9014; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |