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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 pm - 8 am

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Systolic blood pressure

Secondary outcome measures

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,173 Total Patients Enrolled

9 Trials studying Multiple System Atrophy

310 Patients Enrolled for Multiple System Atrophy

Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University Medical Center

Vanderbilt University Medical Center

28 Previous Clinical Trials

1,434 Total Patients Enrolled

12 Trials studying Multiple System Atrophy

427 Patients Enrolled for Multiple System Atrophy

Media Library

Heating pad Clinical Trial Eligibility Overview. Trial Name: NCT03042988 — N/A

Multiple System Atrophy Research Study Groups: Heat Stress, Control (Non-heating)

Multiple System Atrophy 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost capacity of participants in this clinical investigation?

"Affirmative. The entry hosted on clinicaltrials.gov demonstrates that this medical study is actively searching for trial participants, with the initial post dated January 30th 2017 and the most recent update being made on June 1st 2022. There are 20 openings available at a single location."

Answered by AI

Am I qualified to be involved in this medical research?

"Twenty individuals aged 18 to 80, with pure autonomic failure and supine hypertension (systolic BP of 150 mmHg or higher) may be admitted into this trial. Male and female candidates who can provide informed consent are eligible for consideration."

Answered by AI

Is this experiment currently recruiting new participants?

"Yes, according to clinicaltrials.gov this study is still open for recruitment and was initially listed on January 30th, 2017 before receiving its most recent update on the 6th of January 2022. The trial seeks 20 participants from a single site."

Answered by AI