Trial record 1 of 1 for:    Antihypertensives and Vascular, Endothelial and Cognitive Function Trial
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The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial (AVEC)

This study has been completed.
Sponsor:
Collaborators:
Hebrew SeniorLife
Information provided by (Responsible Party):
Ihab Hajjar, University of Southern California
ClinicalTrials.gov Identifier:
NCT00605072
First received: January 11, 2008
Last updated: January 14, 2013
Last verified: January 2013

January 11, 2008
January 14, 2013
January 2008
December 2011   (final data collection date for primary outcome measure)
  • Cognitive Assessment: Trail Making Test Part B [ Time Frame: Baseline-12 months ] [ Designated as safety issue: No ]
    This test requires the connection of sequentially numbered circles (A), and the connection of circles marked by numbers and letters in alternating sequence (B). This test is considered a benchmark of executive function. The test score is the time required to complete the task in seconds.
  • Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall [ Time Frame: Baseline-12 months ] [ Designated as safety issue: No ]
    This is a 12-item list learning test in which individuals are presented three learning and recall trials followed by a delayed recall and 24 item recognition test. The HVLT-R has been identified as an ideal memory measure for elderly patients, and appropriate reliability and validity have been shown in older individuals. The test score is the number of correct answers in the delayed recall ( score range 0-12)
  • Cognitive Assessment: Forward Digit Span Test [ Time Frame: Baseline-12 months ] [ Designated as safety issue: No ]
    This test consists of series of digits of increasing length, some of which are recited as presented, and some of which are to be recited in reversed order. The forward digit span score ranges from 0 (ie cannot repeat two digits) to 8 ( participant can repeat up to 8 digits)
Cognitive assessment measured by Trail Making Test, Hopkins Verbal Learning Test - Revised (HVLT-R), and Digit Span Test [ Time Frame: Baseline, 1 and 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00605072 on ClinicalTrials.gov Archive Site
  • Blood Pressure Outcome: Systolic BP [ Time Frame: Baseline-12 months ] [ Designated as safety issue: No ]
    Blood pressure was measured as follows: the participant was in the sitting position, rested for 5 minutes, no caffeine or smoking 2 hours prior to measurement, using appropriate cuff size (covering 60% of upper arm length and 80% of arm circumference), correct cuff placement (1-2 inches above brachial pulse on bare arm), and the bell of the stethoscope. The systolic blood pressure was defined as the pressure corresponding to the first korotkoff sounds (K1) and the diastolic as the pressure corresponding to the last korotkoff sound (K5). Blood pressure was measured in both arms and recorded
  • Blood Flow Velocity, Sitting [ Time Frame: Baseline-12 months ] [ Designated as safety issue: No ]
    This reports the change in the least square mean from baseline to 12 months, adjusted for age
  • Changes in Cerebral Blood Flow (CBF) and cerebral vasoreactivity [ Time Frame: Baseline, and 6 months after BP control ] [ Designated as safety issue: No ]
  • Endothelial function assessed using the flow mediated dilatation (FMD) procedure [ Time Frame: Baseline, and 6 months after BP control ] [ Designated as safety issue: No ]
  • Biochemical measurement to monitor for adverse events: hyperkalemia, renal failure, leukopenia and liver function abnormalities [ Time Frame: Baseline, 2-4 weeks, 2, 4, and 9 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial
The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial (AVEC Trial)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cognitive Impairment
  • Hypertension
  • Aging
  • Drug: candesartan
    orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
    Other Name: Atacand
  • 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
    Other Name: Prinivil
  • Drug: hydrochlorothiazide
    orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
    Other Name: HCTZ, multiple brand names
  • 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
    Other Name: Procardia XL
  • 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
    Other Name: Lopressor, Toprol XL
  • Experimental: Candesartan
    Angiotensin Receptor Blocker
    Interventions:
    • Drug: candesartan
    • Drug: nifedipine, long acting
    • Drug: metoprolol, long-acting
  • Experimental: Lisinopril
    Angiotensin-Converting Enzyme (ACE) Inhibitor
    Interventions:
    • Drug: lisinopril
    • Drug: nifedipine, long acting
    • Drug: metoprolol, long-acting
  • Active Comparator: HCTZ
    Hydrochlorothiazide (diuretic)
    Intervention: Drug: hydrochlorothiazide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
December 2012
December 2011   (final data collection date for primary outcome measure)

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)
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00605072
IA0127, K23AG030057
No
Ihab Hajjar, University of Southern California
University of Southern California
  • National Institute on Aging (NIA)
  • Hebrew SeniorLife
Principal Investigator: Ihab Hajjar, MD University of Southern California
University of Southern California
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP