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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
Heating pad
Other interventionHeat stress applied on the trunk for up to 8 hours
Sham control
Other interventionheating pad turned off applied on the trunk for up to 8 hours
Treatment groups
Trial outcomes
Primary outcomes
Systolic blood pressure
Maximal change from baseline in systolic blood pressure during the night, measured from 10 pm to 8 am
Secondary outcomes
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
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