Heating Pad for High Blood Pressure

Overseen By Italo Biaggioni, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pregnancy, Cardiac, Renal, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 night per trial session

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether using a heating pad on the abdomen at night can lower high blood pressure in people with autonomic failure when lying down. Autonomic failure can cause high blood pressure when lying down and low blood pressure when standing, which heat might worsen. The trial compares an active heating pad to a sham pad (one that doesn't heat up) to determine its effectiveness in managing high blood pressure. Ideal participants include those with autonomic failure conditions like Parkinson’s Disease, Multiple System Atrophy, or Pure Autonomic Failure, who experience high blood pressure while lying down. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve high blood pressure management in autonomic failure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this heating pad is safe for patients with autonomic failure and supine hypertension?

Research has shown that using a heating pad can safely lower blood pressure. Studies have found that applying heat to the body effectively reduces blood pressure in people with similar conditions. For example, one study discovered that using a heating pad overnight lowered blood pressure in patients with autonomic failure and high blood pressure when lying down.

These studies have reported no major harm from using heat therapy, suggesting that the treatment is generally safe. However, it's important to remember that these findings are based on research, and individual reactions may vary. Always consult your doctor before trying new treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a heating pad for high blood pressure because it offers a non-invasive and drug-free approach to managing the condition. Unlike standard treatments, which often rely on medications like ACE inhibitors or beta-blockers, this method uses passive heat stress by applying a commercial heating pad to the trunk, potentially improving blood flow and reducing blood pressure naturally. This innovative use of heat could provide an alternative for patients seeking to avoid medication-related side effects, offering a simple and user-friendly option for hypertension management.

What evidence suggests that using a heating pad is effective for reducing supine hypertension?

Research has shown that heat therapy can help lower blood pressure. In one study, people using heat therapy experienced a drop of about 5 mmHg in their daytime systolic blood pressure (the top number in a reading), while those not using heat saw little change. Another study found that applying heat locally effectively reduced blood pressure overnight in people with conditions causing high blood pressure when lying down. Heat therapy also improved blood flow in the arteries. In this trial, participants in the "Heat Stress" arm will use a commercial heating pad applied to the trunk to test its effectiveness in managing high blood pressure. Meanwhile, the "Control (Non-heating)" arm will use the same heating pad, but it will be turned off to serve as a sham control. These findings suggest that using heat, such as with a heating pad, might help manage high blood pressure, especially at night. ^{1 3 5 6 7}

Who Is on the Research Team?

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with primary autonomic failure (like Parkinson Disease or Multiple System Atrophy) who also have high blood pressure when lying down. Participants must be able to consent and not be pregnant, nor have significant heart, kidney, or liver diseases that could interfere with the study.

Inclusion Criteria

I am 18-80 years old with Parkinson's, MSA, or PAF and have high blood pressure when lying down.

Patients able and willing to provide informed consent.

Exclusion Criteria

Pregnancy

I do not have major heart, kidney, or liver diseases that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo overnight trials comparing the effects of controlled heat stress versus sham control on nocturnal supine hypertension

1 night per trial session

2 visits (in-person, overnight)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Heating pad
• Sham control

Trial Overview

The study tests if applying heat on the abdomen at night using a heating pad can lower nighttime high blood pressure in patients with autonomic failure. A sham control (a fake treatment used as a comparison) is also used to validate results.

How Is the Trial Designed?

Group I: Heat Stress Experimental Treatment 1 Intervention

Passive heat-stress using a commercial heating pad applied on the trunk

Group II: Control (Non-heating) Placebo Group 1 Intervention

Commercial heating pad applied on the trunk but turned off

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

The Omron HBP-1300 blood pressure device was validated for accuracy in measuring blood pressure in pregnant women, showing a mean difference of only 3 mmHg for systolic and 2 mmHg for diastolic pressure compared to a mercury sphygmomanometer.

The study included 72 pregnant women using either medium or large cuffs, confirming that the Omron HBP-1300 is suitable for both arm sizes, making it a reliable option for monitoring blood pressure during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Omron HBP-1300 in pregnancy for medium-arm and large-arm circumferences according to the British Hypertension Society protocol. Abbud, L., Nzelu, D., Salaria, M., et al.[2021]

The Thai Hypertension Society recommends using automated and validated upper arm cuff devices for home blood pressure monitoring (HBPM) to confirm hypertension diagnoses, starting from the national utilization in 2022.

For effective monitoring, HBPM should be conducted over seven consecutive days, with readings taken twice daily, and target blood pressure levels vary by age, aiming for <125/75 mmHg for those aged 18-65 and <135/85 mmHg for those over 65.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2022 Thai Hypertension Society guidelines on home blood pressure monitoring. Kunanon, S., Roubsanthisuk, W., Chattranukulchai, P., et al.[2023]

The Omron HBP-1100-E blood pressure monitor was tested on 85 Iranian adults and showed significant inaccuracies, with only 26.8% of systolic and 39.6% of diastolic measurements falling within the acceptable range of 5 mmHg compared to standard mercury sphygmomanometers.

The device consistently overestimated blood pressure, with a mean difference of 8.0 mmHg for systolic and 2.2 mmHg for diastolic readings, indicating it is not suitable for accurate blood pressure measurement in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS). Joukar, F., Yeganeh, S., Naghipour, M., et al.[2022]

In a study involving 65 hypertensive patients on haemodialysis, adjusting antihypertensive therapy based on home blood pressure monitoring (HBPM) resulted in significantly lower blood pressure during the interdialytic period compared to adjustments based on predialysis measurements.

The HBPM group showed a notable reduction in systolic blood pressure, indicating that using HBPM can improve blood pressure control in haemodialysis patients, although it did not affect left ventricular mass index after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring in blood pressure control among haemodialysis patients: an open randomized clinical trial. da Silva, GV., de Barros, S., Abensur, H., et al.[2009]

Home blood pressure monitoring (HBPM) is a reliable method for identifying hypertension in heart transplant recipients, accurately classifying 82% of patients in a study of 74 individuals.

Despite a high prevalence of nondipper blood pressure profiles among these patients, HBPM correlates well with ambulatory blood pressure monitoring (ABPM), suggesting it can be effectively used for long-term follow-up in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring in heart transplant recipients: comparison with ambulatory blood pressure monitoring. Ambrosi, P., Kreitmann, B., Habib, G.[2014]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12053574/

Home-based heat therapy lowers blood pressure and ...

Heat therapy reduced ambulatory daytime systolic blood pressure by Δ −5 ± 8 mmHg, but was unchanged for the sham group (Δ 1 ± 6 mmHg; P = 0.04). Likewise, heat ...

2.

physoc.onlinelibrary.wiley.com

physoc.onlinelibrary.wiley.com/doi/10.1113/EP092404

Heat thermotherapy to improve cardiovascular function and ...

A single-bout of HT acutely reduced DBP and MAP and significantly increased peripheral artery shear rate and FMD post-HT. Multiple-bouts of HT ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.120.018979

Local Passive Heat for the Treatment of Hypertension in ...

Conclusions. Local heat therapy effectively lowered overnight BP in patients with autonomic failure and supine hypertension and offers a novel ...

4.

journals.physiology.org

journals.physiology.org/doi/10.1152/japplphysiol.00959.2024

No effect of either heat therapy or aerobic exercise training ...

Although limited, these data suggest that heat therapy may be more effective than exercise training for lowering blood pressure. There is a ...

5.

unthsc.edu

unthsc.edu/newsroom/story/could-heat-therapy-offer-new-treatment-options-for-high-blood-pressure/

Could heat therapy offer new treatment options for high ...

Their findings were recently published in the article titled “Home-based heat therapy lowers blood pressure and improves endothelial function ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8358540/

A systematic review of the role of heat therapy for patients ...

With regard to systolic blood pressure, Akerman et al. demonstrated that heat therapy reduced systolic blood pressure compared to SEP (moderate ES 0.52, 95% CI: ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2468428724002600

Development and feasibility testing of a new device for ...

Exposure to leg HT for 90 minutes using water-circulating trousers resulted in a significant decrease in blood pressure and a substantial increase in popliteal ...