Chronic Lower Leg Heating for the Treatment of Hypertension in Older Women

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The prevalence of hypertension is greater in older women than men, while the blood pressure (BP) control rate is lower in older women in US. Uncontrolled hypertension is a major risk factor for cardiovascular morbidity/mortality. Despite standard therapy and adherence to optimal drug regimens, \>50% of older hypertensive women still have inadequate BP control, and the control rate is further reduced with more aggressive BP targets recommended recently by the new Hypertension Guidelines. Thus, the effectiveness of drug treatment alone in the control of hypertension among older women is limited; hence, non-pharmacological approaches are also needed to help reduce BP in older hypertensive women. One adjuvant, non-pharmacological approach that offers promise in lowering BP is heat therapy. Indeed, repeated whole-body heat exposure decreases BP in healthy humans. Whether this is also true after regional limb heating in hypertensive patients is unknown. The objectives of this research are to investigate the BP lowering effect of home-based lower leg heat therapy in older women with hypertension, and to examine the impact of this therapeutic modality on neural-vascular health in these patients. Aim 1 will test the hypothesis that chronic lower leg heat therapy combined with an antihypertensive drug is superior to drug treatment alone in lowering BP in older hypertensive women. We will randomly assign older hypertensive women to either an intervention group or a control group. Patients in the intervention group will perform 8 weeks of lower leg heat therapy via water immersion up to the knee in a circulated bath (water temperature 42°C, 4 times/week, 45 min/session), whereas patients in the control group will immerse their legs in a thermoneutral water bath (33°C) at the same frequency and duration. All patients will also receive a fixed dose of chlorthalidone (a diuretic, 25 mg orally daily). We will compare ambulatory BP, the BP control rate, and patient adherence and acceptability to treatment between the groups. Aim 2 will test the hypothesis that chronic lower leg heat therapy will improve nitric oxide bioavailability which can decrease sympathetic vasoconstriction and improve vascular function in older hypertensive women. We will use state-of-the-art techniques of microneurography, Doppler ultrasound, applanation tonometry, and cutaneous microdialysis to assess neural control, vasodilator function, and interstitial metabolites (i.e. nitrate and nitrite) indicative of basal nitric oxide bioavailability in all patients enrolled in Aim 1 before and after 8 weeks of heat therapy. Information obtained from this research project will guide evidence-based clinical practice. It is anticipated that our study may lead to revision of hypertension guidelines to incorporate home-based heat therapy as adjuvant to antihypertensive drug(s) for older women, as well as other patient populations.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 65
Maximum Age: 85
Healthy Volunteers: f
View:

• Women between the ages of 65-85 years with essential hypertension (systolic BP 140-179 and/or diastolic BP 90-109 mmHg)

• Must be able to understand and speak English

Locations
United States
Texas
Institute for Exercise and Environmental Medicine
RECRUITING
Dallas
Contact Information
Primary
Qi Fu, MD, PhD
QiFu@texashealth.org
214-345-8125
Backup
Steven Romero, PhD
StevenRomero@unthsc.edu
817-735-5159
Time Frame
Start Date: 2019-07-29
Estimated Completion Date: 2025-12
Participants
Target number of participants: 200
Treatments
Experimental: Intervention
Lower leg heat therapy via water immersion up to the knee in a circulated bath (water temperature 42°C, 4 times per week, 45 minutes per session) for 8 weeks.
Placebo_comparator: Control
Lower leg immerse in a thermoneutral water bath (33°C), 4 times per week, 45 minutes per session for 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov

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