Effects of Continuous Positive Airway Pressure and Valsartan Treatments on Arterial Blood Pressure in OSAS Patients
NCT ID: NCT00409487
Last Updated: 2010-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2006-12-31
2009-05-31
Brief Summary
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Detailed Description
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Nowadays, the most efficient treatment of the OSAS is the continuous Positive Airway Pressure (cPAP). Several studies have also shown that cPAP could reduce arterial blood pressure of about 3,3 mmHg in OSAS patients. Unfortunately, 40% of the patients either refuse being treated by cPAP or give up treatment. In parallel, alternative medications are proposed to patients with moderate OSAS and hypertension, in order to decrease their cardiovascular risks. A study led on rats has shown the superiority of the beta adrenergic blocking agents in the decrease of hypertension in OSAS patients.
Our study has also the objective to compare the effects of Valsartan and cPAP on hypertension in OSAS patients. Those one will be randomized either in the group "treatment by Valsartan and then by cPAP" or in the group "treatment by cPAP and then Valsartan" (cross-over study).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
8 weeks of Valsartant treatment, 4 weeks of washout, 8 weeks of CPAP and 8 weeks of Valsartant plus CPAP treatments
Continuous positive airway pressure (CPAP)
8 weeks of CPAP
Valsartant treatment
8 weeks of Valsartant treatment (160 mg / day)
2
8 weeks of CPAP , 4 weeks of washout, 8 weeks of Valsartant treatment and 8 weeks of Valsartant plus CPAP treatments
Continuous positive airway pressure (CPAP)
8 weeks of CPAP
Valsartant treatment
8 weeks of Valsartant treatment (160 mg / day)
Interventions
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Continuous positive airway pressure (CPAP)
8 weeks of CPAP
Valsartant treatment
8 weeks of Valsartant treatment (160 mg / day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patient with an obstructive sleep apnea (apnea-hypopnea index \> or equal to 15)
* patient with weak or moderate hypertension (140 \<= SBP \< 180 mmHg and 90 \<= DBP \< 110 mmHg). Patient with antihypertensive monotherapy must stop their treatment and respect a washout period of at least 4 weeks before the screening visit. For patient treated by antialdosterone, the washout period will be of at least 8 weeks.
* negative pregnancy test
* ambulatory patient
* patient who have signed the informed consent form
* patient affiliated to social security
Exclusion Criteria
* woman who refuses to use contraceptive method
* acute hepatic failure, biliary cirrhosis, cholestasis
* clearance of Cockcroft \< 30 ml/min/1.73m2
* kaliemia \>= 5.5 mmol/l
* acute hypertension (SBP\>= 180 mmHg and/or DBP \>= 110 mmHg)
* acute daytime sleepiness (Epworth rating scale \> 15)
* patient with a profession that is inconsistent with the continuous positive airway pressure (CPAP) treatment
* known cardiovascular pathologies
* contraindication to CPAP
* allergy to Valsartan
* patient treated with lithium
* patient treated with drug(s) acting on arterial blood pressure
* patient on tutelle or curatelle
* patient kept in detention, major protected by the law, hospitalised person
* patient currently participating in another clinical trial
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Délégation de la Recherche Clinique et de l'Innovation
Principal Investigators
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Jean-Louis JL PEPIN, ProfessorPhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital Grenoble
Grenoble, Grenoble, France
Countries
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References
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Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
Baguet JP, Hammer L, Levy P, Pierre H, Rossini E, Mouret S, Ormezzano O, Mallion JM, Pepin JL. Night-time and diastolic hypertension are common and underestimated conditions in newly diagnosed apnoeic patients. J Hypertens. 2005 Mar;23(3):521-7. doi: 10.1097/01.hjh.0000160207.58781.4e.
Baguet JP, Narkiewicz K, Mallion JM. Update on Hypertension Management: obstructive sleep apnea and hypertension. J Hypertens. 2006 Jan;24(1):205-8. doi: 10.1097/01.hjh.0000198039.39504.63. No abstract available.
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.
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.
Kraiczi H, Hedner J, Peker Y, Grote L. Comparison of atenolol, amlodipine, enalapril, hydrochlorothiazide, and losartan for antihypertensive treatment in patients with obstructive sleep apnea. Am J Respir Crit Care Med. 2000 May;161(5):1423-8. doi: 10.1164/ajrccm.161.5.9909024.
Jordan J, Engeli S, Boschmann M, Weidinger G, Luft FC, Sharma AM, Kreuzberg U. Hemodynamic and metabolic responses to valsartan and atenolol in obese hypertensive patients. J Hypertens. 2005 Dec;23(12):2313-8. doi: 10.1097/01.hjh.0000188734.98463.82.
Calvo C, Hermida RC, Ayala DE, Ruilope LM. Effects of telmisartan 80 mg and valsartan 160 mg on ambulatory blood pressure in patients with essential hypertension. J Hypertens. 2004 Apr;22(4):837-46. doi: 10.1097/00004872-200404000-00028.
Baguet JP, Pepin JL, Hammer L, Levy P, Mallion JM. [Cardiovascular consequences of obstructive sleep apnea syndrome]. Rev Med Interne. 2003 Aug;24(8):530-7. doi: 10.1016/s0248-8663(03)00142-5. French.
Pepin JL, Tamisier R, Barone-Rochette G, Launois SH, Levy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.
Other Identifiers
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0617
Identifier Type: -
Identifier Source: org_study_id