Treatment of Supine Hypertension in Autonomic Failure (CPAP) (NCT 03312556)

Status: Recruitment is temporarily suspended due to COVID-19 outbreak

 

For Diseases:

  • Autonomic Failure
  • Supine Hypertension

Background

Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (e.g., fludrocortisone and pressor agents) worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined.

This study will test the hypothesis that continuous positive airway pressure (CPAP) has an acute lowering-BP effect in autonomic failure patients with supine hypertension. CPAP is a widely-used treatment for sleep-related breathing disorders including sleep apnea, that uses mild air pressure to keep the breathing airways open. It involves using a CPAP machine that blows air into a tube connected to a mask placed over the nose, or nose and mouth. For these studies, a commercial CPAP device will be used to apply pressure sequentially at 0, 4, 8, 12 and 16 cm H2O for 1-20 minute each. Depending on the BP response and tolerability to CPAP, CPAP may be applied during the night using a CPAP level that was tolerable and showed a BP-lowering effect during the acute test.

About this Study

The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension, using a randomized open label crossover study.

Targeted Enrollment

12 participants estimated to be completed September 21, 2021

Eligibility:

  • Ages Eligible for Study: 18 Years to 85 Years (adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

  • Patients with autonomic failure and with supine hypertension from all races

Exclusion Criteria:

  • Patients with autonomic failure and with supine hypertension from all races
  • Pregnant women
  • High-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction)
  • History of serious allergies or asthma

How to participate

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation