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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT03042988
Status
Recruiting
Apply to this trial

Conditions

  • Autonomic Failure
  • Hypertension
  • Multiple System Atrophy
  • Pure Autonomic Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Heating pad — OTHER
    Heat stress applied on the trunk for up to 8 hours
  • Sham control — OTHER
    heating pad turned off applied on the trunk for up to 8 hours

Study Details

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.

Key Dates

Start date
Jan 30, 2017
Status verified
Jan 2026
Primary completion
Nov 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Autonomic Dysfunction Center/ Vanderbilt University Medical CenterNashvilleTennessee37232
Emily C Smith, RN
[email protected]
615.875.1516
Bonnie K Black, RN
[email protected]
615-322-3304
Bonnie K Black, RN (SUB_INVESTIGATOR)
Luis E Okamoto, MD (SUB_INVESTIGATOR)
David Robertson, MD (SUB_INVESTIGATOR)
Italo Biaggioni, MD (PRINCIPAL_INVESTIGATOR)
Alfredo Gamboa, MD (SUB_INVESTIGATOR)
Cyndya A Shibao, MD (SUB_INVESTIGATOR)
Andre Diedrich, MD, PhD (SUB_INVESTIGATOR)
jorge Celedonio, MD (SUB_INVESTIGATOR)
Emily C Smith, RN (SUB_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Autonomic Dysfunction Center/ Vanderbilt University Medical Center· Nashville, TN

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