Local Passive Heat for the Treatment of Hypertension in Autonomic Failure.
Luis E Okamoto, Jorge E Celedonio, Emily C Smith...
https://pubmed.ncbi.nlm.nih.gov/33739123Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID03042988
Overnight Trials to Compare the Effects of Controlled Heat Stress Versus Sham Control on Nocturnal Supine Hypertension in Autonomic Failure Patients
Led by Vanderbilt University Medical Center · Updated on 2026-01-16
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with autonomic failure often experience disabling low blood pressure when standing (orthostatic hypotension) and high blood pressure when lying down (supine hypertension). This condition can worsen with heat exposure, but the reasons are not fully understood. This research aims to evaluate whether applying local heat over the abdomen during the night can reduce high blood pressure in these patients. Understanding this may help improve treatment for supine hypertension in autonomic failure. The study compares the effects of passive heat stress using a commercial heating pad applied to the trunk during the night against a sham control where the heating pad is turned off. Each treatment is applied for up to 8 hours in a randomized crossover design. This approach will help assess the safety and effectiveness of local heat stress in lowering nocturnal blood pressure in patients with autonomic failure and supine hypertension. Participants will have their blood pressure monitored overnight from 10 pm to 8 am. Researchers will also evaluate how well participants tolerate standing the following morning through a 10-minute standing test. The study tracks blood pressure changes and orthostatic tolerance to better understand treatment effects. The trial is expected to continue until the end of 2026, with participants involved during treatment nights and morning assessments afterwards.
CONDITIONS
Brief Title
Overnight Trials With Heat Stress in Autonomic Failure Patients With Supine Hypertension
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female patients between 18 and 80 years old with primary autonomic failure (Parkinson Disease, Multiple System Atrophy, Pure Autonomic Failure) and supine hypertension (systolic blood pressure ≥150 mmHg)
- Patients able and willing to provide informed consent
You will not qualify if you...
- Pregnancy
- Significant cardiac, renal, or hepatic illness
- Contraindications to administration of pressor agents
- Other conditions preventing completion of the protocol, including clinically significant abnormalities in clinical, mental, or laboratory testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 8 hours per intervention night
Participants receive passive heat stress using a heating pad applied on the trunk or a sham control during the night to assess effects on nocturnal blood pressure.
Multiple overnight visits to receive heat stress or sham control in a randomized crossover design
Trial Site Locations
Total: 1 location
1
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
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Research Team
B
Bonnie K Black, RN
I
Italo Biaggioni, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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