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| Name | Class |
|---|---|
| Financiadora de Estudos e Projetos | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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The aim is to evaluate the effect of treatment with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory blood pressures (BP) of 200 resistant hypertensive patients with moderate-severe obstructive sleep apnea syndrome (OSAS).
Obstructive sleep apnea syndromes (OSAS) have been demonstrated to be highly prevalent in patients with resistant hypertension (defined as uncontrolled clinic BP despite being on anti-hypertensive treatment with at least 3 drugs in optimal doses and including a diuretic). Nevertheless, the effect of treating OSAS with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory BPs in patients with resistant hypertension is largely unknown. Hence, the primary aim of this randomized clinical trial is to evaluate the effect of CPAP on BP levels in resistant hypertensive patients with moderate-severe OSAS (defined as an apnea-hypopnea index [AHI] greater than 15 on a full polysomnographic examination). Two-hundred patients will be randomly allocated either to treatment with CPAP device plus their usual anti-hypertensive treatment or to continue their usual treatment alone for 6 months. Clinic and 24-hour ambulatory BP monitoring, laboratory evaluation (including microalbuminuria and aldosterone-to-renin ratio), 24-hour Holter monitoring, ergospirometric treadmill test, and carotid-femoral pulse wave velocity measurement will be performed before and after the 6-month treatment, with the observers blinded to the allocation group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP | Active Comparator | Treatment with Continuous Positive Airway Pressure |
|
| Control | No Intervention | Usual anti-hypertensive treatment without CPAP treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure treatment | Procedure | Treatment with CPAP for 6 months, pressure will be titrated during a second polysomnography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinic and ambulatory blood pressures | Clinic and ambulatory blood pressures (during 24-hour ambulatory blood pressure monitoring, which included both daytime and nighttime blood pressures, as well as the nocturnal dipping pattern). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Microalbuminuria | Urinary albumin excretion rate on 24-hour urine collection | 6 months |
| Aldosterone excess measurements | Serum aldosterone concentration, plasma renin activity, aldosterone-to-renin ratio and 24-hour urinary aldosterone excretion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gil F Salles, PhD | Department of Internal Medicine, Faculty of Medicine, federal University of Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Program of Arterial Hypertension, University Hospital Clementino Fraga Filho | Rio de Janeiro | Rio de Janeiro | 21941-913 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14732721 | Background | Goodfriend TL, Calhoun DA. Resistant hypertension, obesity, sleep apnea, and aldosterone: theory and therapy. Hypertension. 2004 Mar;43(3):518-24. doi: 10.1161/01.HYP.0000116223.97436.e5. Epub 2004 Jan 19. | |
| 11725173 | Background | Logan AG, Perlikowski SM, Mente A, Tisler A, Tkacova R, Niroumand M, Leung RS, Bradley TD. High prevalence of unrecognized sleep apnoea in drug-resistant hypertension. J Hypertens. 2001 Dec;19(12):2271-7. doi: 10.1097/00004872-200112000-00022. |
| Label | URL |
|---|---|
| Related Info | View source |
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| 6 months |
| Arterial stiffness | Carotid-femoral pulse wave velocity and aortic pulse wave contour analysis (which include aortic systolic and pulse pressure and augmentation index) | 6 months |
| Autonomic system measurements | Measures of autonomic system balance derived from 24-hour Holter monitoring, which includes heart rate variability on time and frequency domains. | 6 months |
| Cardiorespiratory fitness | Cardiorespiratory fitness by 6 min walking test with maximum oxigen consumption measurement and by complete ergospirometric treadmill test. | 6 months |
| 11560187 | Background | Lavie P, Hoffstein V. Sleep apnea syndrome: a possible contributing factor to resistant. Sleep. 2001 Sep 15;24(6):721-5. doi: 10.1093/sleep/24.6.721. |
| 17393240 | Background | Alajmi M, Mulgrew AT, Fox J, Davidson W, Schulzer M, Mak E, Ryan CF, Fleetham J, Choi P, Ayas NT. Impact of continuous positive airway pressure therapy on blood pressure in patients with obstructive sleep apnea hypopnea: a meta-analysis of randomized controlled trials. Lung. 2007 Mar-Apr;185(2):67-72. doi: 10.1007/s00408-006-0117-x. Epub 2007 Mar 28. |
| 17452537 | Background | Haentjens P, Van Meerhaeghe A, Moscariello A, De Weerdt S, Poppe K, Dupont A, Velkeniers B. The impact of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea syndrome: evidence from a meta-analysis of placebo-controlled randomized trials. Arch Intern Med. 2007 Apr 23;167(8):757-64. doi: 10.1001/archinte.167.8.757. |
| 21106625 | Background | Duran-Cantolla J, Aizpuru F, Montserrat JM, Ballester E, Teran-Santos J, Aguirregomoscorta JI, Gonzalez M, Lloberes P, Masa JF, De La Pena M, Carrizo S, Mayos M, Barbe F; Spanish Sleep and Breathing Group. Continuous positive airway pressure as treatment for systemic hypertension in people with obstructive sleep apnoea: randomised controlled trial. BMJ. 2010 Nov 24;341:c5991. doi: 10.1136/bmj.c5991. |
| 20577130 | Background | Lozano L, Tovar JL, Sampol G, Romero O, Jurado MJ, Segarra A, Espinel E, Rios J, Untoria MD, Lloberes P. Continuous positive airway pressure treatment in sleep apnea patients with resistant hypertension: a randomized, controlled trial. J Hypertens. 2010 Oct;28(10):2161-8. doi: 10.1097/HJH.0b013e32833b9c63. |
| 32048379 | Derived | Cardoso CRL, Roderjan CN, Cavalcanti AH, Cortez AF, Muxfeldt ES, Salles GF. Effects of continuous positive airway pressure treatment on aortic stiffness in patients with resistant hypertension and obstructive sleep apnea: A randomized controlled trial. J Sleep Res. 2020 Aug;29(4):e12990. doi: 10.1111/jsr.12990. Epub 2020 Feb 12. |
| 28129246 | Derived | de Souza F, Muxfeldt ES, Margallo V, Cortez AF, Cavalcanti AH, Salles GF. Effects of continuous positive airway pressure treatment on aldosterone excretion in patients with obstructive sleep apnoea and resistant hypertension: a randomized controlled trial. J Hypertens. 2017 Apr;35(4):837-844. doi: 10.1097/HJH.0000000000001254. |
| 25601933 | Derived | Muxfeldt ES, Margallo V, Costa LM, Guimaraes G, Cavalcante AH, Azevedo JC, de Souza F, Cardoso CR, Salles GF. Effects of continuous positive airway pressure treatment on clinic and ambulatory blood pressures in patients with obstructive sleep apnea and resistant hypertension: a randomized controlled trial. Hypertension. 2015 Apr;65(4):736-42. doi: 10.1161/HYPERTENSIONAHA.114.04852. Epub 2015 Jan 19. |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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