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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Heating pad

    Other intervention

    Heat stress applied on the trunk for up to 8 hours

  • Sham control

    Other intervention

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Heat StressExperimental treatment 1 intervention
Group B: Control (Non-heating)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Systolic blood pressure

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

Time frame
10 pm - 8 am

Secondary outcomes

1

Orthostatic Tolerance the following morning

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

Time frame
10 min standing

Other outcomes

Sponsors and contacts

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