Heat application for managing high blood pressure in patients with autonomic failure
Overnight Trials to Compare the Effects of Controlled Heat Stress Versus Sham Control on Nocturnal Supine Hypertension in Autonomic Failure Patients
This study is testing if using a heating pad on the belly at night can help people with autonomic failure lower their high blood pressure while lying down.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT03042988 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of applying local heat to the abdomen of patients with autonomic failure and supine hypertension during the night. The aim is to determine if this intervention can reduce nocturnal high blood pressure while lying down. Patients with conditions such as Parkinson's Disease, Multiple System Atrophy, and Pure Autonomic Failure will be included. The study will compare the effects of the heating pad against a sham control to assess efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with primary autonomic failure and supine hypertension.
Not a fit: Patients with significant cardiac, renal, or hepatic illnesses, or those who are pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for managing supine hypertension in patients with autonomic failure.
How similar studies have performed: Preliminary results suggest that heat exposure may worsen orthostatic hypotension, indicating that this approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nashville, Tennessee
- Autonomic Dysfunction Center/ Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Italo Biaggioni, MD — Vanderbilt University Medical Center
- Study coordinator: Bonnie K Black, RN
- Email: autonomics@vumc.org
- Phone: 615-343-6862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.