To assess whether temporary discontinuation of antihypertensive therapy in mildly cognitively impaired older patients on antihypertensive treatment improves cognitive and psychological functioning.
ID
Bron
Verkorte titel
Aandoening
antihypertensive therapy - cognitive functioning - elderly
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
To assess whether temporary discontinuation of antihypertensive therapy in mildly cognitively impaired older patients on antihypertensive treatment improves cognitive and psychological functioning.
Onderzoeksopzet
Baseline measurement and 4 months of follow-up.
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. A history of myocardial infarction, stroke, coronary reperfusion procedures (CABG/PCI) < 3 years;
2. Heart failure requiring antihypertensive medication.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2300 |
| NTR-old | NTR2829 |
| Ander register | METC LUMC / ZonMw : P10.208 / 40-41600-98-9014; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |