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| ID | Type | Description | Link |
|---|---|---|---|
| 200124 | Other Identifier | Vanderbilt IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo pill or patch or sham CPAP | Placebo Comparator | Placebo pill or patch or sham CPAP |
|
| CPAP (continuous positive airway pressure) | Active Comparator | Continuous positive airway pressure during the night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous positive airway pressure (CPAP) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Supine Systolic Blood Pressure | change in supine systolic blood pressure from baseline | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary volume | Nocturnal urinary volume | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bonnie K Black, RN | Contact | 615-343-6862 | autonomics@vumc.org | |
| Luis E Okamoto, MD | Contact | (615) 936-6119 | autonomics@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Italo Biaggioni, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Autonomic Dysfunction Center/ Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36601916 | Derived | 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. |
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| ID | Term |
|---|---|
| D054970 | Pure Autonomic Failure |
| D006973 | Hypertension |
| D019578 | Multiple System Atrophy |
| C564247 | Microcephaly, Primary Autosomal Recessive, 6 |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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|
| Placebo | Drug | Placebo pill or patch. Single dose |
|
|
| D002318 | Cardiovascular Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012138 |
| Respiratory Therapy |