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NCT Number: NCT03042988

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Alfredo Gamboa, MD

SUB_INVESTIGATOR

Andre Diedrich, MD, PhD

SUB_INVESTIGATOR

Bonnie K Black, RN

CONTACT

[email protected]

615-322-3304

Bonnie K Black, RN

SUB_INVESTIGATOR

Cyndya A Shibao, MD

SUB_INVESTIGATOR

David Robertson, MD

SUB_INVESTIGATOR

Emily C Smith, RN

CONTACT

[email protected]

615.875.1516

Emily C Smith, RN

SUB_INVESTIGATOR

Italo Biaggioni, MD

PRINCIPAL_INVESTIGATOR

Luis E Okamoto, MD

SUB_INVESTIGATOR

jorge Celedonio, MD

SUB_INVESTIGATOR

About this study

Primary autonomic failure is a neurodegenerative condition characterized by loss of efferent sympathetic function and severe baroreflex impairment. The clinical hallmark of autonomic failure is disabling orthostatic hypotension, but at least half of patients are also hypertensive while lying down. This supine hypertension can be severe and associated with end-organ damage and worsening of orthostatic hypotension due to increased pressure natriuresis. It also complicates the management of these patients by limiting the use of daytime pressor agents for the treatment of orthostatic hypotension. Currently, no antihypertensive drug effectively lowers BP and prevents pressure natriuresis without worsening standing BP.

It is well known that heat exposure (e.g. hot weather or a hot bath or shower) produces an acute and temporary worsening of orthostatic hypotension in autonomic failure patients. Factors that may predispose these patients to the lowering BP effects of heat stress include 1) impaired heat dissipation due to inability to sweat, 2) preserved heat-mediated skin vasodilation, and 3) blunted sympathetic hemodynamic responses to maintain BP (increases in cardiac output, heart rate, and vaso- and venoconstriction). Our preliminary results showed that 2 hours of passive heat stress lowers BP in these patients through a decrease in central volume. In this study, we will assess the efficacy and safety of passive heat stress in the treatment of nocturnal supine hypertension in autonomic failure patients. Our hypothesis is that controlled local (abdominal) passive heat stress applied during the night will lower nocturnal BP in autonomic failure patients with supine hypertension.

To test this hypothesis, we propose to compare the BP effects of passive heat applied during the night vs. a sham control in a randomized crossover study in autonomic failure patients with supine hypertension.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Heating pad

Other

Heat stress applied on the trunk for up to 8 hours

Other names: Local heat stress

Sham control

Other

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

Other names: control

Primary outcomes

  1. Systolic blood pressure

    Time frame: 10 pm - 8 am

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

Secondary outcomes

  1. Orthostatic Tolerance the following morning

    Time frame: 10 min standing

    Orthostatic tolerance defined as the area under the curve of standing systolic blood pressure calculated by the trapezoidal rule (upright systolic blood pressure multiplied by standing time) during a 10-minute standing test

Study contacts

Contact information is provided by the study sponsor or research team.

Bonnie K Black, RN

CONTACT

[email protected]

615-343-6862

Italo Biaggioni, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2017
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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