N/A
N=22
Local Heat Stress in Autonomic Failure Patients With Supine Hypertension
Hypertension · Pure Autonomic Failure · Multiple System Atrophy · Autonomic Failure
Bottom Line
View on ClinicalTrials.gov: NCT02417415 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Change in Systolic Blood Pressure — 19; 3 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Passive heat stress (Other); Control (non-heating) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure |
19; 3 | — |
| SECONDARY Percent Change in Hemodynamic Parameters (Cardiac Output, Stroke Volume and Systemic Vascular Resistance) |
-15; -2; -18; -4; 9; 4 | — |
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 would decrease their 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
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.
Data sourced from ClinicalTrials.gov (NCT02417415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.