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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Tennessee
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Bonnie K Black, RN
autonomics@vumc.org
615-343-6862
Backup
Italo Biaggioni, MD
autonomics@vumc.org
Time Frame
Start Date: 2017-01-30
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 20
Treatments
Experimental: Heat Stress
Passive heat-stress using a commercial heating pad applied on the trunk
Sham_comparator: Control (Non-heating)
Commercial heating pad applied on the trunk but turned off
Authors
Andre Diedrich, Italo Biaggioni
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov