The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to examine the effects of blood pressure medications on cognition and blood flow in hypertensive elderly patients with cognitive impairment. The hypothesis is that treatment with an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme inhibitor (ACEI) will be associated with a slower rate of further cognitive decline, improved cerebral blood flow and its regulation, and preserved physical function as compared to treatment with a diuretic (HCTZ), independent of blood pressure level.

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Detailed Description

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There is mounting evidence that hypertension, which affects more than 65% of the US elderly population, accelerates cognitive decline and increases the risk of functional disability among older individuals. Hypertension is also associated with cerebral blood flow reduction and dysregulation which contribute to further cognitive and functional impairment. Drugs that inhibit angiotensin II (ACEI and ARB) are commonly used antihypertensives and may have a protective effect on cognitive function, cerebral blood flow and physical function compared to other antihypertensives such as hydrochlorothiazide (HCTZ).

A total of 100 individuals will be recruited for this pilot 3-arm randomized study to investigate the effects of: (i) 12 months treatment with candesartan (ARB) compared to hydrochlorothiazide (HCTZ) and (ii) 12 months treatment with lisinopril (ACEI) compared to HCTZ and (iii) to estimate the effect size difference between lisinopril and losartan on cognition, cerebral blood flow regulation, and functional measures in a sample of elderly hypertensive individuals with objective evidence of cognitive impairment.

Conditions

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Cognitive Impairment Hypertension Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Candesartan

Angiotensin Receptor Blocker

Group Type EXPERIMENTAL

candesartan

Intervention Type DRUG

orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months

nifedipine, long acting

Intervention Type DRUG

If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

metoprolol, long-acting

Intervention Type DRUG

If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg

Lisinopril

Angiotensin-Converting Enzyme (ACE) Inhibitor

Group Type EXPERIMENTAL

lisinopril

Intervention Type DRUG

orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months

nifedipine, long acting

Intervention Type DRUG

If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

metoprolol, long-acting

Intervention Type DRUG

If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg

HCTZ

Hydrochlorothiazide (diuretic)

Group Type ACTIVE_COMPARATOR

hydrochlorothiazide

Intervention Type DRUG

orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months

Interventions

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candesartan

orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months

Intervention Type DRUG

lisinopril

orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months

Intervention Type DRUG

hydrochlorothiazide

orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months

Intervention Type DRUG

nifedipine, long acting

If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

Intervention Type DRUG

metoprolol, long-acting

If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg

Intervention Type DRUG

Other Intervention Names

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Atacand Prinivil HCTZ, multiple brand names Procardia XL Lopressor, Toprol XL

Eligibility Criteria

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Inclusion Criteria

* 60 years or older
* Hypertension
* Cognitive criteria: score either 10 or less out of 15 for the executive clock draw test 1 (CLOX1) or less than or equal to 1 standard deviation from the corresponding age specific mean on the immediate memory subtest