Treatment of Supine Hypertension in Autonomic Failure (CPAP)

Official title

Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure

Overview

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. The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension.

Detailed description

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 (eg, 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.

Interventions

• Device continuous positive airway pressure (CPAP)
  Continuous positive airway pressure(CPAP) will be applied during the night starting from 20:00. CPAP level will be determined during an acute CPAP trial.
• Drug Placebo
  Placebo pill or patch. Single dose

Primary outcome measures

• Supine Systolic Blood Pressure [Time frame: 12 hours]

Secondary outcome measures (1)

• Urinary volume [Time frame: 12 hours]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• All medical students
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Autonomic Dysfunction Center/ Vanderbilt University Medical Center — Nashville

Publications

• Okamoto LE, Celedonio JE, Smith EC, Paranjape SY, Black BK, Wahba A, Park JW, Shibao CA, Diedrich A, Biaggioni I. Continuous Positive Airway Pressure for the Treatment of Supine Hypertension and Orthostatic Hypotension in Autonomic Failure. Hypertension. 2023 Mar;80(3):650-658. doi: 10.1161/HYPERTENSIONAHA.122.20081. Epub 2023 Jan 5. PMID 36601916

Identifiers

NCT: NCT03312556 · 010189-1 · 200124

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗