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Effects of temporary discontinuation of antihypertensive treatment in older patients with cognitive impairment: A randomised controlled trial.


- candidate number9286
- NTR NumberNTR2829
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-mrt-2011
- Secondary IDsP10.208 / 40-41600-98-9014; METC LUMC / ZonMw
- Public TitleEffects of temporary discontinuation of antihypertensive treatment in older patients with cognitive impairment: A randomised controlled trial.
- Scientific TitleEffects of temporary discontinuation of antihypertensive treatment in older patients with cognitive impairment: A randomised controlled trial.
- ACRONYMDANTE-Leiden
- hypothesisTo assess whether temporary discontinuation of antihypertensive therapy in mildly cognitively impaired older patients on antihypertensive treatment improves cognitive and psychological functioning.
- Healt Condition(s) or Problem(s) studiedOlder adults, Cognitive functioning, Antihypertensive therapy
- Inclusion criteria1. 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 criteria1. A history of myocardial infarction, stroke, coronary reperfusion procedures (CABG/PCI) < 3 years;
2. Heart failure requiring antihypertensive medication.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate1-sep-2013
- Target number of participants400
- InterventionsPatients will be randomized to either continuation (n=200) or discontinuation (n=200) of antihypertensive treatment. Discontinuation of antihypertensive medication by patientsí 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.
- Primary outcomePrimary 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 outcomeAt 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 Cantrilís 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 Cantrilís ladder.
- TimepointsBaseline measurement and 4 months of follow-up.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. R.C. Mast, van der
- CONTACT for SCIENTIFIC QUERIESProf. dr. R.C. Mast, van der
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBlood 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.
- Main changes (audit trail)
- RECORD29-mrt-2011 - 8-apr-2011


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