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Heating Pad for High Blood Pressure

N/A
Recruiting
Led By Italo Biaggioni, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female patients, between 18-80 yrs., with primary autonomic failure (Parkinson Disease, Multiple System Atrophy, and Pure Autonomic Failure) and supine hypertension. Supine hypertension will be defined as SBP≥150 mmHg.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 pm - 8 am

Summary

This trial will test whether applying local heat to the abdomen of patients with autonomic failure and supine hypertension at night decreases their nocturnal high blood pressure.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from the heat, skin irritation where the heating pad is applied, and possible worsening of low blood pressure symptoms when standing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18-80 years old with Parkinson's, MSA, or PAF and have high blood pressure when lying down.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 pm - 8 am
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 pm - 8 am for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Systolic blood pressure
Secondary study objectives
Orthostatic Tolerance the following morning

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Heat StressExperimental Treatment1 Intervention
Passive heat-stress using a commercial heating pad applied on the trunk
Group II: Control (Non-heating)Placebo Group1 Intervention
Commercial heating pad applied on the trunk but turned off

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
902 Previous Clinical Trials
938,481 Total Patients Enrolled
Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
28 Previous Clinical Trials
1,434 Total Patients Enrolled

Media Library

Heating pad Clinical Trial Eligibility Overview. Trial Name: NCT03042988 — N/A
High Blood Pressure Research Study Groups: Heat Stress, Control (Non-heating)
High Blood Pressure Clinical Trial 2023: Heating pad Highlights & Side Effects. Trial Name: NCT03042988 — N/A
Heating pad 2023 Treatment Timeline for Medical Study. Trial Name: NCT03042988 — N/A
~0 spots leftby Nov 2024
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