NCT03042988 Overnight Trials With Heat Stress in Autonomic Failure Patients With Supine Hypertension
| NCT ID | NCT03042988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2017-01-30 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2017-01-30 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Italo Biaggioni, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT03042988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03042988 currently recruiting?
Yes, NCT03042988 is actively recruiting participants. Contact the research team at autonomics@vumc.org for enrollment information.
Where is the NCT03042988 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT03042988 clinical trial?
NCT03042988 is sponsored by Vanderbilt University Medical Center. The principal investigator is Italo Biaggioni, MD at Vanderbilt University Medical Center. The trial plans to enroll 20 participants.