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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR2829
• Date of registration: 29/03/2011
• Primary sponsor: Leiden University Medical Center (LUMC)
• Public title: Effects of temporary discontinuation of antihypertensive treatment in older patients with cognitive impairment: A randomised controlled trial.
• Scientific title: Effects of temporary discontinuation of antihypertensive treatment in older patients with cognitive impairment: A randomised controlled trial. - DANTE-Leiden
• Date of first enrolment: 1/9/2011
• Target sample size: 400
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2829
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: R.C. Mast, van der

• Name: R.C. Mast, van der

Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Older adults, Cognitive functioning, Antihypertensive therapy

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

P10.208 / 40-41600-98-9014;

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development