Expired Study
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Boston, Massachusetts 02131


Purpose:

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.


Study summary:

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.


Criteria:

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 Exclusion Criteria: - Intolerance to ACEI or ARB - History of congestive heart failure - History of diabetes mellitus - History of stroke (less than 6 months)


Study is Available At:


Original ID:

IA0127


NCT ID:

NCT00605072


Secondary ID:

K23AG030057


Study Acronym:

AVEC


Brief Title:

The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial


Official Title:

The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial (AVEC Trial)


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hebrew Rehabilitation Center, Boston


Oversight Authority:

  • United States: Federal Government
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Ihab Hajjar, MD
Principal Investigator
Hebrew SeniorLife

Study Dates

Start Date:January 2008
Completion Date:December 2011
Completion Type:Anticipated
Primary Completion Date:December 2011
Primary Completion Type:Anticipated
Verification Date:March 2011
Last Changed Date:March 17, 2011
First Received Date:January 11, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Biochemical measurement to monitor for adverse events: hyperkalemia, renal failure, leukopenia and liver function abnormalities
Time Frame:Baseline, 2-4 weeks, 2, 4, 9, and 12 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Endothelial function assessed using the flow mediated dilatation (FMD) procedure
Time Frame:Baseline, then 6 and 12 months after BP control
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in Cerebral Blood Flow (CBF) and cerebral vasoreactivity
Time Frame:Baseline, then 6 and 12 months after BP control
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Cognitive assessment measured by Trail Making Test, Hopkins Verbal Learning Test - Revised (HVLT-R), and Digit Span Test
Time Frame:Baseline, 1, 6, and 12 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:candesartan
Description:orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
Arm Name:ARB
Other Name:Atacand
Intervention Type:Drug
Name:lisinopril
Description:orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
Arm Name:ACEI
Other Name:Prinivil
Intervention Type:Drug
Name:hydrochlorothiazide
Description:orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
Arm Name:HCTZ
Other Name:HCTZ, multiple brand names
Intervention Type:Drug
Name:nifedipine, long acting
Description: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
Arm Name:ARB
Other Name:Procardia XL
Intervention Type:Drug
Name:metoprolol, long-acting
Description: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
Arm Name:ARB
Other Name:Lopressor, Toprol XL

Study Arms

Study Arm Type:Experimental
Arm Name:ARB
Description:Angiotensin Receptor Blocker
Study Arm Type:Experimental
Arm Name:ACEI
Description:Angiotensin-Converting Enzyme (ACE) Inhibitor
Study Arm Type:Active Comparator
Arm Name:HCTZ

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Hebrew Rehabilitation Center, Boston
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Lipsitz LA, Gagnon M, Vyas M, Iloputaife I, Kiely DK, Sorond F, Serrador J, Cheng DM, Babikian V, Cupples LA. Antihypertensive therapy increases cerebral blood flow and carotid distensibility in hypertensive elderly subjects. Hypertension. 2005 Feb;45(2):216-21. Epub 2005 Jan 17.
PMID:15655124
Reference Type:Reference
Citation:Waldstein SR, Katzel LI. Gender differences in the relation of hypertension to cognitive function in older adults. Neurol Res. 2004 Jul;26(5):502-6.
PMID:15265267
Reference Type:Reference
Citation:Pugh KG, Kiely DK, Milberg WP, Lipsitz LA. Selective impairment of frontal-executive cognitive function in african americans with cardiovascular risk factors. J Am Geriatr Soc. 2003 Oct;51(10):1439-44.
PMID:14511165
Reference Type:Reference
Citation:Kuo HK, Sorond F, Iloputaife I, Gagnon M, Milberg W, Lipsitz LA. Effect of blood pressure on cognitive functions in elderly persons. J Gerontol A Biol Sci Med Sci. 2004 Nov;59(11):1191-4.
PMID:15602074

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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