Cognitive/Cerebrovascular Consequences of HTN Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2007-05-31

Brief Summary

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Randomized trial of two antihypertensive drugs of known efficacy to investigate whether one has more favorable effects on brain blood flow and cognitive function.

Detailed Description

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The project examines the neuropsychological status, peripheral blood flow, and structural cortical (magnetic resonance imaging, MRI) and functional cortical blood flow (quantitative positron emission tomography, PET) status of previously unmedicated hypertensives. These individuals are then medicated for one year with one of two effective blood pressure medications. Our hypothesis is that the angiotensin-converting enzyme inhibitor, but not the beta-blocker will normalize cerebral blood flow and possibly, cognitive function. This hypothesis is tested by a repetition of our initial examinations at the completion of one year of treatment.

Conditions

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Hypertension

Keywords

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cerebral blood flow, positron emission tomography, magnetic resonance imaging, neuropsychology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atenolol (drug), Lisinopril (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All subjects will be between 35 and 65 years of age, and must have a diastolic BP between 90 and 109 mm Hg, systolic BP between 140 and 179 mm Hg, or both. Eligibility will be based upon readings taken at two screening visits. For resting BP determinations, eating, smoking, drinking and heavy physical activity will be proscribed for 1 hour prior, and drinking caffeinated beverages 2 hours prior. Systolic and diastolic (5th phase) BP will be determined twice separated by 2 minutes using a 2-3 mm Hg/sec deflation rate. Before readings, a 60 s resting pulse will be obtained. Two readings over two such sessions will be averaged. All measurements will be obtained by individuals certified in BP measurement by the Department of Epidemiology of the Graduate School of Public Health.

Potential subjects must have either no prior pharmacologic treatment for hypertension or minimal lifetime exposure. The latter is defined as no more than 6 months of blood pressure medication within the past 5 years. No blood pressure medication taken at all in the 6 months preceding study enrollment. To establish medical eligibility and to screen for secondary causes of hypertension, subjects will provide a medical history and have their standard blood chemistry determined to screen for occult renal failure and primary hyperaldosteronism. All women will be postmenopausal or tested (urine specimen) to ensure the absence of pregnancy. To ensure their ability to complete the behavioral assessments, subjects must have at least an 8th grade education and immigrants must have spoken English as their primary language for at least five years.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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J. Richard Jennings, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh, Dept of Psychiatry

Locations

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Dept of Psychiatry, University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Jennings JR, Muldoon MF, Ryan C, Price JC, Greer P, Sutton-Tyrrell K, van der Veen FM, Meltzer CC. Reduced cerebral blood flow response and compensation among patients with untreated hypertension. Neurology. 2005 Apr 26;64(8):1358-65. doi: 10.1212/01.WNL.0000158283.28251.3C.

Reference Type BACKGROUND

PMID: 15851723 (View on PubMed)

Other Identifiers

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R01HL057529

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HyperPetII

Identifier Type: -

Identifier Source: org_study_id