Cognitive/Cerebrovascular Consequences of HTN Treatment

NCT00151138 | Completed

• 2 other identifiers: HyperPetIIR01HL057529
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cerebral blood flow in response to working memory task

Secondary Outcomes (1)

• Neuropsychological function

Interventions

Atenolol (drug), Lisinopril (drug) DRUG

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Dept of Psychiatry, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 15851723 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Atenolol; Pharmaceutical Preparations; Lisinopril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• J. Richard Jennings, PhD

  University of Pittsburgh, Dept of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: September 1, 2002
• Study Completion: May 1, 2007
• Last Updated: December 17, 2007

Record last verified: 2007-12

Locations

US (1)