Heat Therapy in Older Hypertensive Women
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.
Conditions:
🦠 Essential Hypertension
🗓️ Study Start (Actual)
29 July 2019
🗓️ Primary Completion (Estimated)
February 2025
✅ Study Completion (Estimated)
February 2025
👥 Enrollment (Estimated)
200
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Dallas, Texas, United States
Description
Inclusion Criteria:
- * 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
Exclusion Criteria:
- * Illness or disabilities that preclude home-based heat therapy
- * Any evidence of cardiopulmonary disease
- * Severe hypertension (BP ≥180/110 mmHg; for safety reasons)
- * Secondary hypertension
- * Being on ≥3 antihypertensive agents
- * Chronic kidney disease
- * Diabetes mellitus or other systemic illness
- * Any history of substance abuse (other than tobacco)
- * Current cigarette smokers
- * History of gouty arthritis
- * Taking hormonal replacement therapy
- * Being obese (body mass index ≥30 kg/m2)
- * Endurance trained athletes
- * Impaired cognitive function or diagnosed dementia
Ages Eligible for Study:
65 Years to 85 Years (OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
No
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
22 February 2019
- First Submitted that Met QC Criteria
25 February 2019
- First Posted
28 February 2019
Study Record Updates
- Last Update Submitted that Met QC Criteria
10 June 2024
- Last Update Posted
12 June 2024
- Last Verified
June 2024