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

NCT00409487 | Completed Phase 4 DMC

• 1 other identifier: 0617
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension,; Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; hypertension; ambulatory bloop pressure monitoring

Outcome Measures

Primary Outcomes (1)

• ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), 8 weeks, 12 weeks, and 20 weeks

  24 h

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

8 weeks of Valsartant treatment, 4 weeks of washout, 8 weeks of CPAP and 8 weeks of Valsartant plus CPAP treatments

Device: Continuous positive airway pressure (CPAP); Drug: Valsartant treatment

2

EXPERIMENTAL

8 weeks of CPAP , 4 weeks of washout, 8 weeks of Valsartant treatment and 8 weeks of Valsartant plus CPAP treatments

Device: Continuous positive airway pressure (CPAP); Drug: Valsartant treatment

Interventions

Continuous positive airway pressure (CPAP) DEVICE

8 weeks of CPAP

Also known as: CPAP treatment

1; 2

Valsartant treatment DRUG

8 weeks of Valsartant treatment (160 mg / day)

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, Grenoble, 38000, France

Location

Related Publications (10)

• 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.

  PMID: 12748199 BACKGROUND

• 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.

  PMID: 15716692 BACKGROUND

• 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.

  PMID: 16331122 BACKGROUND

• 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.

  PMID: 11812555 BACKGROUND

• 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.

  PMID: 12515745 BACKGROUND

• 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.

  PMID: 10806134 BACKGROUND

• 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.

  PMID: 16269974 BACKGROUND

• 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.

  PMID: 15126927 BACKGROUND

• 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.

  PMID: 12888174 BACKGROUND

• 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.

  PMID: 20522795 DERIVED

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jean-Louis JL PEPIN, ProfessorPhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 11, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: May 1, 2009
• Last Updated: September 8, 2010

Record last verified: 2010-09

Locations

FR (1)