Chronic Lower Leg Heating for the Treatment of Hypertension in Older Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Physiological parameter (awake ambulatory systolic pressure)
研究概览
简要总结
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.
详细描述
We expect that over a period of 6 years, 500 older hypertensive women will be screened, 200 of them will be enrolled, and 100 will complete the entire project.
Aim 1: To test the hypothesis that chronic 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 be required to perform 8 weeks of home-based lower leg heat therapy via water immersion up to the knee in a circulated bath (water temperature 42°C, 4 times per week, 45 min per 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 once daily). We will compare 24-hour ambulatory BP, the BP control rate, and patient adherence and acceptability to treatment between the groups.
Aim 2: To test the hypothesis that chronic 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 and applanation tonometry to assess sympathetic neural control and cardiac-vascular function in all patients enrolled in Aim 1 before and after 8 weeks of heat therapy.
Study Procedures:
Screening: Potential participants will be invited into the laboratory where a research nurse and investigators will have the patient read the institutionally approved consent form and explain the study. Informed consent will be obtained prior to screening. After that, we will perform a physical exam, a review of medical history and medication, and a further evaluation of inclusion and exclusion criteria in potential patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The randomization will be programmed with SAS Proc Plan and implemented via a user friendly web-based interface using REDCap. The biostatistician will be responsible for randomization; however, he/she will not have any contact with the patients and will not be involved in outcome measures. All investigators, except the research nurses, will be blinded to the group status of the patient during 8-week treatment and post-treatment testing. The research nurses will not be involved in data analysis and interpretation.
入排标准
- 年龄范围
- 60 Years 至 85 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 60-85 years with essential hypertension (systolic BP 140-179 and/or diastolic BP 90-109 mmHg)
- •Must be able to understand and speak English
排除标准
- •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
研究组 & 干预措施
Control
Lower leg immerse in a thermoneutral water bath (33°C), 4 times per week, 45 minutes per session for 8 weeks.
干预措施: Lower leg heat therapy (Behavioral)
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.
干预措施: Lower leg heat therapy (Behavioral)
结局指标
主要结局
Physiological parameter (awake ambulatory systolic pressure)
时间窗: After 8 weeks of treatment.
24-hour ambulatory blood pressure monitoring will be performed and systolic blood pressure during the awake period before and after treatment will be compared in older women with hypertension.
Physiological parameter (vascular function)
时间窗: After 8 weeks of treatment.
We will use the Ultrasound Doppler technique to measure vascular function including arterial stiffness and endothelial function in older hypertension women before and after treatment. Results will be compared between the groups.
Physiological parameter (muscle sympathetic nerve activity)
时间窗: After 8 weeks of treatment.
We will us the microneurographic technique to measure muscle sympathetic nerve activity in all older hypertensive women before and after treatment. Results will be compared between the intervention group and the control group.
次要结局
未报告次要终点
研究者
Qi Fu
Professor of Medicine
University of Texas Southwestern Medical Center
