Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03857490 · ClinicalTrials.gov registry record · NA
Heat Therapy in Older Hypertensive Women
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 134
- Enrollment target
NCT03857490: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT03857490 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 134 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03857490, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 134 participants
- Enrollment target
Study 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 a
Primary Outcome
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.
Interventions
- BEHAVIORAL Lower leg heat therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2019-07-29 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the finished NCT03857490 record still lists
NCT03857490 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Lower leg heat therapy is the first listed.
NCT03857490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03857490 about?
NCT03857490 is a clinical study titled "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%...
What is the current status of trial NCT03857490?
This trial is currently completed. It is a NA study. The enrollment target is 134 participants. The study started on 2019-07-29. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT03857490?
The interventions under investigation include: Lower leg heat therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03857490?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03857490's enrollment target sits among peer trials
134 728th of 2000 higher than 1,272 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02469662 · 134 participants · NA
Clinical Outcomes Study of the Nexel Total Elbow
- NCT03110822 · 134 participants · Phase 1
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients
- NCT04678648 · 134 participants · Phase 1
A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
- NCT05264857 · 134 participants · NA
Decision Aid and Thyroid Nodules Management
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI