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

NCT03042988 | Recruiting

• 2 other identifiers: VR22699141523
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Pure Autonomic Failure; Multiple System Atrophy; Autonomic Failure

Keywords

supine hypertension; autonomic failure; heat stress; orthostatic hypotension

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  Maximal change from baseline in systolic blood pressure during the night, measured from 10 pm to 8 am

  10 pm - 8 am

Secondary Outcomes (1)

• Orthostatic Tolerance the following morning

  10 min standing

Study Arms (2)

Heat Stress

EXPERIMENTAL

Passive heat-stress using a commercial heating pad applied on the trunk

Other: Heating pad

Control (Non-heating)

SHAM COMPARATOR

Commercial heating pad applied on the trunk but turned off

Other: Sham control

Interventions

Heating pad OTHER

Heat stress applied on the trunk for up to 8 hours

Also known as: Local heat stress

Heat Stress

Sham control OTHER

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

Also known as: control

Control (Non-heating)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (1)

• Okamoto LE, Celedonio JE, Smith EC, Gamboa A, Shibao CA, Diedrich A, Paranjape SY, Black BK, Muldowney JAS 3rd, Peltier AC, Habermann R, Crandall CG, Biaggioni I. Local Passive Heat for the Treatment of Hypertension in Autonomic Failure. J Am Heart Assoc. 2021 Apr 6;10(7):e018979. doi: 10.1161/JAHA.120.018979. Epub 2021 Mar 19.

  PMID: 33739123 DERIVED

MeSH Terms

Conditions

Hypertension; Pure Autonomic Failure; Multiple System Atrophy; Heat Stress Disorders; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Wounds and Injuries; Orthostatic Intolerance; Hypotension

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bonnie K Black, RN

CONTACT

615-343-6862; autonomics@vumc.org

Italo Biaggioni, MD

CONTACT

autonomics@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Model Details: randomized, 2-arm crossover study (heat vs sham)

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 3, 2017
• Study Start: January 30, 2017
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)