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Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight weeks in an ambulatory set. The investigators want to determine any difference on hypertension control between the 2 management strategies.
This is a double blind, randomized, placebo controlled trial. Participants were consecutive patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. All participants should have a diagnosis of at least moderate OSAS, defined by AHI > 15 in a portable monitoring sleep exam. Participants were assigned to active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active CPAP | Active Comparator | auto-PAP with therapeutic pressure |
|
| sham-CPAP | Sham Comparator | auto-PAP with pressure less than 1cm H2O |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active CPAP | Device | auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring | 8 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| aldosterone, renin, activated protein C | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavio D Fuchs | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035003 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25084263 | Derived | de Oliveira AC, Martinez D, Massierer D, Gus M, Goncalves SC, Ghizzoni F, Steinhorst AM, Moreira LB, Fuchs SC, Fuchs FD. The antihypertensive effect of positive airway pressure on resistant hypertension of patients with obstructive sleep apnea: a randomized, double-blind, clinical trial. Am J Respir Crit Care Med. 2014 Aug 1;190(3):345-7. doi: 10.1164/rccm.201403-0479LE. No abstract available. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
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| sham-CPAP | Device | The sham-CPAP was the same equipment used for active CPAP (Respironics Remstar-Auto, Murraysville, PA) fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al. The differences between the two were undetectable except for the pressure generated in the facial mask in the sham-CPAP that was no greater than 1cm H2O. |
|
| D012140 |
| Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |