Effects of Continuous Positive Airway Pressure and Valsartan Treatments on Arterial Blood Pressure in OSAS Patients

Obstructive Sleep Apnea Clinical Trial

— VALSAS  

Official title:

Comparative Study of Effect of Valsartan 160mg Treatment Versus Continuous Positive Airway Pressure on Arterial Blood Pressure in Patients Who Have an Obstructive Sleep Apnea Syndrome and a Weak or Moderate Hypertension.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409487
• Other study ID #: 0617
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2006
• Last updated: September 7, 2010
• Start date: December 2006
• Est. completion date: May 2009

Study information

• Verified date: September 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The main objective of the study is to compare the decrease of mean arterial blood pressure over 24 hours in patients having obstructive sleep apnea syndrome and weak or moderate hypertension, treated by Valsartan 160mg per day versus continuous Positive Airway Pressure.

Description:

It is now well known that cardiovascular risks are increased in patients with obstructive sleep apnea syndrome (OSAS). Also a link has already been demonstrated between OSAS and hypertension.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2009
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male/female over than 18 years old

• 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:

• pregnant or nursing woman

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension,
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous positive airway pressure (CPAP)
8 weeks of CPAP

Drug:
• Valsartant treatment
8 weeks of Valsartant treatment (160 mg / day)

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (9)

Baguet JP, Hammer L, Lévy P, Pierre H, Rossini E, Mouret S, Ormezzano O, Mallion JM, Pépin JL. Night-time and diastolic hypertension are common and underestimated conditions in newly diagnosed apnoeic patients. J Hypertens. 2005 Mar;23(3):521-7. — View Citation

Baguet JP, Narkiewicz K, Mallion JM. Update on Hypertension Management: obstructive sleep apnea and hypertension. J Hypertens. 2006 Jan;24(1):205-8. — View Citation

Baguet JP, Pépin JL, Hammer L, Lévy P, Mallion JM. [Cardiovascular consequences of obstructive sleep apnea syndrome]. Rev Med Interne. 2003 Aug;24(8):530-7. Review. French. — View 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. — View Citation

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. — View Citation

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. Epub 2003 May 14. Erratum in: JAMA. 2003 Jul 9;290(2):197. — View Citation

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), 8 weeks, 12 weeks, and 20 weeks		24 h	Yes
Secondary	clinical blood pressure measurement at inclusion, 8 weeks, 12 weeks, and 20 weeks; pulse wave speed at inclusion, 8 weeks, 12 weeks, and 20 weeks; baroreceptor reflex at inclusion, 8 weeks, 12 weeks, and 20 weeks.		1 h	Yes