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

Primary Purpose

Hypertension, Pure Autonomic Failure, Multiple System Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heating pad
Sham control
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring supine hypertension, autonomic failure, heat stress, orthostatic hypotension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Autonomic Dysfunction Center/ Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Heat Stress

Control (Non-heating)

Arm Description

Passive heat-stress using a commercial heating pad applied on the trunk

Commercial heating pad applied on the trunk but turned off

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 1, 2017
Last Updated
March 17, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03042988
Brief Title
Overnight Trials With Heat Stress in Autonomic Failure Patients With Supine Hypertension
Official Title
Overnight Trials to Compare the Effects of Controlled Heat Stress Versus Sham Control on Nocturnal Supine Hypertension in Autonomic Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pure Autonomic Failure, Multiple System Atrophy, Autonomic Failure
Keywords
supine hypertension, autonomic failure, heat stress, orthostatic hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized, 2-arm crossover study (heat vs sham)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heat Stress
Arm Type
Experimental
Arm Description
Passive heat-stress using a commercial heating pad applied on the trunk
Arm Title
Control (Non-heating)
Arm Type
Sham Comparator
Arm Description
Commercial heating pad applied on the trunk but turned off
Intervention Type
Other
Intervention Name(s)
Heating pad
Other Intervention Name(s)
Local heat stress
Intervention Description
Heat stress applied on the trunk for up to 8 hours
Intervention Type
Other
Intervention Name(s)
Sham control
Other Intervention Name(s)
control
Intervention Description
heating pad turned off applied on the trunk for up to 8 hours
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
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 Outcome Measure Information:
Title
Orthostatic Tolerance the following morning
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily C Smith, RN
Phone
615.875.1516
Email
autonomics@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Bonnie K Black, RN
Phone
615-322-3304
Email
autonomics@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily C Smith, RN
Phone
615-875-1516
Email
autonomics@vumc.org
First Name & Middle Initial & Last Name & Degree
Bonnie K Black, RN
Phone
615-322-3304
Email
autonomics@vumc.org
First Name & Middle Initial & Last Name & Degree
Bonnie K Black, RN
First Name & Middle Initial & Last Name & Degree
Luis E Okamoto, MD
First Name & Middle Initial & Last Name & Degree
David Robertson, MD
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, MD
First Name & Middle Initial & Last Name & Degree
Alfredo Gamboa, MD
First Name & Middle Initial & Last Name & Degree
Cyndya A Shibao, MD
First Name & Middle Initial & Last Name & Degree
Andre Diedrich, MD, PhD
First Name & Middle Initial & Last Name & Degree
jorge Celedonio, MD
First Name & Middle Initial & Last Name & Degree
Emily C Smith, RN

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33739123
Citation
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.
Results Reference
derived

Learn more about this trial

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

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