Clinical trial NCT06287580: Effects of Antihypertensive Drug Treatment on Brain Blood Flow, Cognition, and Regulation of Nervous System in Older Adults with Hypertension.
Official title: Antihypertensive Drug Effects on Cerebral Hemodynamics and Sympathetic Control in Older Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Essential Hypertension
Older Adults
Keywords: antihypertensive drug
cerebral blood flow
cognitive function
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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 \&gt;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

Primary outcomes:
measure: Change in Muscle sympathetic nerve activity (MSNA) from baseline at 2 weeks post intervention
timeFrame: Baseline, 2 weeks post intervention
measure: Change in cognitive performance from baseline at 2 weeks post intervention via Stroop Color and Word Test
timeFrame: Baseline, 2 weeks post intervention
measure: Change in cognitive performance from baseline at 2 weeks post intervention via NIH Toolbox Cognitive Battery
timeFrame: Baseline, 2 weeks post intervention
measure: Change in Cerebral blood flow from baseline at 2 weeks post intervention
timeFrame: Baseline, 2 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Institute for Exercise and Environmental Medicine
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: TAKURO WASHIO, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: