Hypertension Clinical Trial
Official title:
Local Heat Stress in Autonomic Failure Patients With Supine Hypertension
NCT number | NCT02417415 |
Other study ID # | 141523 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | February 2021 |
Verified date | December 2021 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | February 2021 |
Est. primary completion date | February 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Systolic Blood Pressure | Change from baseline in systolic blood pressure at 2 hr post-intervention | 2 hours of heat stress or sham | |
Secondary | Percent Change in Hemodynamic Parameters (Cardiac Output, Stroke Volume and Systemic Vascular Resistance) | Percent change from baseline ([post-intervention - baseline]/baseline X 100) in cardiac output, stroke volume and systemic vascular resistance at 2 hours post-intervention | 2 hours of heat stress or sham |
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