Recruiting

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT03042988

Conditions

Hypertension

Pure Autonomic Failure

Multiple System Atrophy

Autonomic Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Heating pad

Sham control

Study Details

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

Study ID

NCT03042988

Start date

Jan 30, 2017

Status verified date

Jan, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Heating pad

Heat stress applied on the trunk for up to 8 hours

Sham control

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

Primary outcome measure

  • Systolic blood pressure [ Time Frame: 10 pm - 8 am ]

Central Contacts and Locations

Central contacts

Italo Biaggioni, MD

autonomics@vumc.org

Locations

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

Italo Biaggioni, MD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • supine hypertension
  • autonomic failure
  • heat stress
  • orthostatic hypotension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-01-16.