Clinical trial NCT00881985: Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension
Official title: Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Drug-resistant Hypertension : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistant Hypertension
Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
resistant hypertension
refractory hypertension
continuous positive airway pressure
blood pressure control
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA).

Detailed description: Resistant hypertension is defined as blood pressure that remains above goal in spite of concurrent use of 3 antihypertensive agents of different classes. Resistant hypertension is defined in order to identify patients who are at risk of having secondary causes of hypertension, and who may benefit from specific diagnostic and therapeutic applications. Despite the fact that OSA is listed as one of the causes of resistant HT , paucity of works has demonstrated the magnitude of problems of untreated OSA in subjects with resistant HT. There is so far two study demonstrating the beneficial effect of CPAP treatment in subjects with resistant HT, though both studies were flawed by not including the control group, no randomization and limited sample size. We aim at conducting a randomized controlled study to explore the beneficial effect of CPAP treatment in subjects with OSA and resistant hypertension.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 65
* known hypertension on ≧ 3 anti-hypertensive drugs
* Apnea-hypopnea index ≧15
* able to give informed written consent

Exclusion Criteria:

* moderate renal impairment (glomerular filtration rate \<30 mL/min/m2 )
* endocrine/renal/cardiac causes of secondary HT
* congestive heart failure and clinically fluid overloaded
* On drugs that elevates BP e.g. NSAID, steroid
* Non-compliance to anti-hypertensive medications
* Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months
* Active inflammatory/infective conditions e.g. rheumatoid arthritis
* Excessive sleepiness that can be risky e.g. occupational driver, machine operator
* Modification/changes of anti-hypertensive regimen within 8 weeks

Primary outcomes:
measure: mean systolic blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: mean arterial blood pressure
timeFrame: 8 weeks
measure: mean diastolic blood pressure
timeFrame: 8 weeks
measure: high sensitivity C-reactive protein
timeFrame: 8 weeks
measure: cardiac injury marker
timeFrame: 8 weeks
measure: oxidative stress marker
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Mary SM Ip, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829.
citation: Young T, Peppard P, Palta M, Hla KM, Finn L, Morgan B, Skatrud J. Population-based study of sleep-disordered breathing as a risk factor for hypertension. Arch Intern Med. 1997 Aug 11-25;157(15):1746-52.
citation: Pepperell JC, Ramdassingh-Dow S, Crosthwaite N, Mullins R, Jenkinson C, Stradling JR, Davies RJ. Ambulatory blood pressure after therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised parallel trial. Lancet. 2002 Jan 19;359(9302):204-10. doi: 10.1016/S0140-6736(02)07445-7.
citation: Becker HF, Jerrentrup A, Ploch T, Grote L, Penzel T, Sullivan CE, Peter JH. Effect of nasal continuous positive airway pressure treatment on blood pressure in patients with obstructive sleep apnea. Circulation. 2003 Jan 7;107(1):68-73. doi: 10.1161/01.cir.0000042706.47107.7a.
citation: Norman D, Loredo JS, Nelesen RA, Ancoli-Israel S, Mills PJ, Ziegler MG, Dimsdale JE. Effects of continuous positive airway pressure versus supplemental oxygen on 24-hour ambulatory blood pressure. Hypertension. 2006 May;47(5):840-5. doi: 10.1161/01.HYP.0000217128.41284.78. Epub 2006 Apr 3.
citation: Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM. Resistant hypertension: diagnosis, evaluation, and treatment. A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Hypertension. 2008 Jun;51(6):1403-19. doi: 10.1161/HYPERTENSIONAHA.108.189141. Epub 2008 Apr 7.
citation: 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.
citation: Grote L, Hedner J, Peter JH. Sleep-related breathing disorder is an independent risk factor for uncontrolled hypertension. J Hypertens. 2000 Jun;18(6):679-85. doi: 10.1097/00004872-200018060-00004.
citation: 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.
citation: Logan AG, Tkacova R, Perlikowski SM, Leung RS, Tisler A, Floras JS, Bradley TD. Refractory hypertension and sleep apnoea: effect of CPAP on blood pressure and baroreflex. Eur Respir J. 2003 Feb;21(2):241-7. doi: 10.1183/09031936.03.00035402.
citation: Martinez-Garcia MA, Gomez-Aldaravi R, Soler-Cataluna JJ, Martinez TG, Bernacer-Alpera B, Roman-Sanchez P. Positive effect of CPAP treatment on the control of difficult-to-treat hypertension. Eur Respir J. 2007 May;29(5):951-7. doi: 10.1183/09031936.00048606. Epub 2007 Feb 14.
citation: Lui MM, Tse HF, Lam DC, Lau KK, Chan CW, Ip MS. Continuous positive airway pressure improves blood pressure and serum cardiovascular biomarkers in obstructive sleep apnoea and hypertension. Eur Respir J. 2021 Nov 4;58(5):2003687. doi: 10.1183/13993003.03687-2020. Print 2021 Oct.