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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26485

Enrollment

400

Registered

2011-03-29

Start date

2011-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

antihypertensive therapy - cognitive functioning - elderly

Interventions

Patients will be randomized to either continuation (n=200) or discontinuation (n=200) of antihypertensive treatment. Discontinuation of antihypertensive medication by patients’ own general practitione

Eligibility

Inclusion 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

Exclusion criteria: 1. A history of myocardial infarction, stroke, coronary reperfusion procedures (CABG/PCI) < 3 years; 2. Heart failure requiring antihypertensive medication.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactR.C. Mast, van der

Dept. of Psychiatry Leiden University Medical Center PO Box 9600

r.c.van_der_mast@lumc.nl+31 (0)71 5263785

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)