Heating Pad for High Blood Pressure

Recruiting in Palo Alto (17 mi)

Overseen by Italo Biaggioni, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pregnancy, Cardiac, Renal, Hepatic, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Patients with autonomic failure are characterized by disabling orthostatic hypotension (low blood pressure on standing), and at least half of them also have high blood pressure while lying down (supine hypertension). Exposure to heat, such as in hot environments, often worsens their orthostatic hypotension. The causes of this are not fully understood. The purpose of this study is to evaluate whether applying local heat over the abdomen of patients with autonomic failure and supine hypertension during the night would decrease their nocturnal high blood pressure while lying down. This will help us better understand the mechanisms underlying this phenomenon, and may be of use in the treatment of supine hypertension.

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.

How does the heating pad treatment for high blood pressure differ from other treatments?

The heating pad treatment for high blood pressure is unique because it uses heat application as a non-drug approach to manage blood pressure, unlike traditional treatments that often involve medication. This method may offer a novel way to relax blood vessels and improve circulation, potentially reducing blood pressure without the side effects associated with medications. ^{1 2 3 4 5}

Research Team

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Heating pad (Behavioural Intervention)
• Sham control (Behavioural Intervention)

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.

Participant Groups

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+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring in heart transplant recipients: comparison with ambulatory blood pressure monitoring. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring in blood pressure control among haemodialysis patients: an open randomized clinical trial. [2009]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

2022 Thai Hypertension Society guidelines on home blood pressure monitoring. [2023]

5. New Zealand 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). [2022]