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| ID | Type | Description | Link |
|---|---|---|---|
| 141523 | Other Identifier | Vanderbilt IRB |
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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.
Primary autonomic failure is a neurodegenerative condition characterized by loss of efferent sympathetic function and severe baroreflex impairment. The clinical hallmark of autonomic failure is disabling orthostatic hypotension, but at least half of patients are also hypertensive while lying down. This supine hypertension can be severe and associated with end-organ damage and worsening of orthostatic hypotension due to increased pressure natriuresis. It also complicates the management of these patients by limiting the use of daytime pressor agents for the treatment of orthostatic hypotension. Currently, no antihypertensive drug effectively lowers BP and prevents pressure natriuresis without worsening standing BP.
It is well known that heat exposure (e.g. hot weather or a hot bath or shower) produces an acute and temporary worsening of orthostatic hypotension in autonomic failure patients. Factors that may predispose these patients to the lowering BP effects of heat stress include 1) impaired heat dissipation due to inability to sweat, 2) preserved heat-mediated skin vasodilation, and 3) blunted sympathetic hemodynamic responses to maintain BP (increases in cardiac output, heart rate, and vaso- and venoconstriction). Our preliminary results showed that 2 hours of passive heat stress lowers BP in these patients through a decrease in central volume. In this study, we will assess the efficacy and safety of passive heat stress in the treatment of nocturnal supine hypertension in autonomic failure patients. Our hypothesis is that controlled local (abdominal) passive heat stress applied during the night will lower nocturnal BP in autonomic failure patients with supine hypertension.
To test this hypothesis, we propose to compare the BP effects of passive heat applied during the night vs. a sham control in a randomized crossover study in autonomic failure patients with supine hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat Stress | Experimental | Passive heat-stress using a commercial heating pad applied on the trunk |
|
| Control (Non-heating) | Sham Comparator | Commercial heating pad applied on the trunk but turned off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heating pad | Other | Heat stress applied on the trunk for up to 8 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | Maximal change from baseline in systolic blood pressure during the night, measured from 10 pm to 8 am | 10 pm - 8 am |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 min standing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bonnie K Black, RN | Contact | 615-343-6862 | autonomics@vumc.org | |
| Italo Biaggioni, MD | Contact | autonomics@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Italo Biaggioni, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Autonomic Dysfunction Center/ Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33739123 | Derived | Okamoto LE, Celedonio JE, Smith EC, Gamboa A, Shibao CA, Diedrich A, Paranjape SY, Black BK, Muldowney JAS 3rd, Peltier AC, Habermann R, Crandall CG, Biaggioni I. Local Passive Heat for the Treatment of Hypertension in Autonomic Failure. J Am Heart Assoc. 2021 Apr 6;10(7):e018979. doi: 10.1161/JAHA.120.018979. Epub 2021 Mar 19. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D054970 | Pure Autonomic Failure |
| D019578 | Multiple System Atrophy |
| D018882 | Heat Stress Disorders |
| D007024 | Hypotension, Orthostatic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
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randomized, 2-arm crossover study (heat vs sham)
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| Sham control | Other | heating pad turned off applied on the trunk for up to 8 hours |
|
|
| D009422 | Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D014947 | Wounds and Injuries |
| D054971 | Orthostatic Intolerance |
| D007022 | Hypotension |