RecruitingNot ApplicableNCT03042988

Overnight Trials With Heat Stress in Autonomic Failure Patients With Supine Hypertension

Overnight Trials to Compare the Effects of Controlled Heat Stress Versus Sham Control on Nocturnal Supine Hypertension in Autonomic Failure Patients


Sponsor

Vanderbilt University Medical Center

Enrollment

20 participants

Start Date

Jan 30, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • 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.
  • Patients able and willing to provide informed consent.

Exclusion Criteria2

  • Pregnancy
  • Significant cardiac, renal or hepatic illness, or with contraindications to administration of pressor agents or with other factors, which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing.

Interventions

OTHERHeating pad

Heat stress applied on the trunk for up to 8 hours

OTHERSham control

heating pad turned off applied on the trunk for up to 8 hours


Locations(1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT03042988


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