Effects of Antihypertensive Drug Treatment on Brain Blood Flow, Cognition, and Regulation of Nervous System in Older Adults With Hypertension.

Essential Hypertension Clinical Trial

Official title:

Antihypertensive Drug Effects on Cerebral Hemodynamics and Sympathetic Control in Older Hypertensive Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06287580
• Other study ID #: STU-2024-0140
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 15, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: TAKURO WASHIO, Ph.D.
• Phone: 214-345-4852
• Email: TakuroWashio[@]texashealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High blood pressure (BP) is a public health problem worldwide. Nearly three-quarters of older adults (age ~60 years) in the United States have high BP. High BP links to many health problems, like stroke. Drug treatments are typically used in clinics to reduce high BP and the risk of associated health problems. However, these drug treatments may not always benefit brain health. For example, drug treatment may reduce brain blood flow, which may reduce cognitive function in older adults with high BP. Alternatively, reduced brain blood flow may cause high BP due to increased nervous system activity (the so-called "fight or flight response"). Thus, monitoring brain blood flow may help to manage high BP during drug treatment.

It is unknown if brain blood flow and its control will be altered by drug treatment in older high BP patients. Therefore, study team will recruit older adults with high BP, who receive either drug treatment or a placebo for 2 weeks and will assess brain blood flow, cognitive function, and nervous system control before and after treatment.

Results from this study will provide novel and clinically relevant information on the impact of drug treatment for high BP on brain health. Investigators expect these results will suggest that it is crucial to measure brain blood flow, which may be a therapeutic new target for BP control and brain health.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Older men and women with mild-to-moderate essential hypertension (60-85 years, clinic systolic BP 130-159 and/or diastolic BP 80-109 mmHg)

Exclusion Criteria:

• Any evidence of cardiovascular or pulmonary disease by medical history or by physical examination

• Severe hypertension (systolic BP =160 and/or diastolic BP =110 mmHg; for safety reasons) or secondary hypertension

• Being on =3 antihypertensive agents

• Chronic kidney disease (an estimated glomerular filtration rate >45 mL/min) or renal failure

• Diabetes mellitus (fasting glucose =126 mg/dL or 2-hour oral glucose tolerance test, glucose level =200 mg/dL) or other systemic illness

• Any history of substance abuse (other than tobacco)

• Current cigarette smokers

• History of gouty arthritis

• Taking hormonal replacement therapy

• Endurance-trained athletes

• Diagnosed Alzheimer's disease and related dementias

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Older Adults

Intervention

Drug:
• chlorthalidone 25 mg
chlorthalidone, 25 mg orally once daily

Other:
• Placebo
Placebo tablet taken orally once daily

Locations

Country	Name	City	State
United States	Institute for Exercise and Environmental Medicine	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Muscle sympathetic nerve activity (MSNA) from baseline at 2 weeks post intervention	Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve. Muscle sympathetic nerve activity will be quantified by identification and measurement of sympathetic bursts in the integrated neurogram and expressed as burst frequency (mean number of bursts per unit time)	Baseline, 2 weeks post intervention
Primary	Change in cognitive performance from baseline at 2 weeks post intervention via Stroop Color and Word Test	Change in cognitive performance is measured by Stroop Color and Word Test. Accuracy and reaction time in the Stroop Color and Word test are computed to assess cognitive performance.	Baseline, 2 weeks post intervention
Primary	Change in cognitive performance from baseline at 2 weeks post intervention via NIH Toolbox Cognitive Battery	Change in cognitive performance is measured by NIH Toolbox Cognitive Battery that yields individual test scores and the following summary scores: Total Cognition Composite, Fluid Composite (includes Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory, List Sorting Working Memory, and Pattern Comparison tests), and Crystallized Composite (includes Picture Vocabulary and Oral Reading Recognition tests). The NIH Toolbox Cognitive Battery results convert to uncorrected standard scores (mean±standard deviation, 100±15), where higher indicate better outcome.	Baseline, 2 weeks post intervention
Primary	Change in Cerebral blood flow from baseline at 2 weeks post intervention	A probe will be placed over an artery in participant's neck and temple. Total cerebral blood flow is calculated as a sum of blood flow from the four arteries of the internal carotid artery and vertebral artery. The distribution of cardiac output to the brain is calculated as the percentage of total cerebral blood flow to cardiac output.	Baseline, 2 weeks post intervention