Local Heat Stress in Autonomic Failure Patients With Supine Hypertension

NCT02417415 | Completed Results

• 1 other identifier: 141523
• Study Type: interventional
• Target: 22
• 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 would decrease their 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 intolerance; Orthostatic hypotension; Heat stress

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure

  Change from baseline in systolic blood pressure at 2 hr post-intervention

  2 hours of heat stress or sham

Secondary Outcomes (1)

• Percent Change in Hemodynamic Parameters (Cardiac Output, Stroke Volume and Systemic Vascular Resistance)

  2 hours of heat stress or sham

Study Arms (2)

Local Heat Stress

EXPERIMENTAL

Passive heat-stress using a commercial heating pad applied over the abdomen and part of the torso

Other: Passive heat stress

Control (Non-heating)

SHAM COMPARATOR

Commercial heating pad applied over the abdomen and part of the torso but turned off

Other: Control (non-heating)

Interventions

Passive heat stress OTHER

Passive heat stress will be applied with a commercial heating pad that covers all the abdomen and part of the torso to provide local heating at \~44ºC continuously for 2 hr.

Also known as: Heating pad

Local Heat Stress

Control (non-heating) OTHER

Heating pad will be applied over the abdomen and part of the torso but it will be turned off.

Also known as: sham

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: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

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; Hypotension, Orthostatic; Heat Stress Disorders

Interventions

salicylhydroxamic acid

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; Orthostatic Intolerance; Hypotension; Wounds and Injuries

Results Point of Contact

• Title: Italo Biaggioni
• Organization: Vanderbilt University Medical Center

italo.biaggioni@vumc.org

(615) 322-2318

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were blinded to the intervention
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

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

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 15, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 10, 2022
• Results First Posted: March 10, 2022

Record last verified: 2021-12

Locations

US (1)