Effects of Continuous Positive Airway Pressure and Valsartan Treatments on Arterial Blood Pressure in OSAS Patients - Full Text View

Sponsored by:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00409487

Purpose

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.

Condition	Intervention	Phase
Hypertension, Obstructive Sleep Apnea	Device: Continuous positive airway pressure (CPAP) Drug: Valsartant treatment	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Sleep Apnea

Drug Information available for: Valsartan

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), 8 weeks, 12 weeks, and 20 weeks [ Time Frame: 24 h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: 1 h ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2009
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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) 8 weeks of CPAP Drug: Valsartant treatment 8 weeks of Valsartant treatment (160 mg / day)
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) 8 weeks of CPAP Drug: Valsartant treatment 8 weeks of Valsartant treatment (160 mg / day)

Detailed 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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409487

Contacts

Contact: Jean-Louis JP PEPIN, ProfessorPhD

0033476768759

JPepin@chu-grenoble.fr

Locations

France
University Hospital Grenoble	Recruiting
Grenoble, France, 38000
Contact: Jean-Louis JP PEPIN, ProfessorPhD 33476768759 JPepin@chu-grenoble.fr
Principal Investigator: Jean-Louis JP PEPIN, ProfessorPhD
Sub-Investigator: Jean-Philippe JB BAGUET, ProfessorPhD
Sub-Investigator: Renaud RT TAMISIER, PhD
Sub-Investigator: Patrick PL LEVY, ProfessorPhD

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator:

Jean-Louis JL PEPIN, ProfessorPhD

University Hospital, Grenoble

More Information

Publications:

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.

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.

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

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.

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.

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.

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.

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. Review. French.

Responsible Party:	Délégation de la Recherche Clinique et de l'Innovation ( University Hospital, Grenoble )
Study ID Numbers:	0617
Study First Received:	December 8, 2006
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00409487 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

obstructive sleep apnea
hypertension
ambulatory bloop pressure monitoring

Study placed in the following topic categories:

Sleep Apnea Syndromes
Apnea
Asthenia
Sleep Apnea, Obstructive
Respiration Disorders
Vascular Diseases
Sleep Disorders

Dyssomnias
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Valsartan
Hypertension

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Apnea
Nervous System Diseases
Sleep Apnea, Obstructive
Respiration Disorders
Vascular Diseases
Dyssomnias

Sleep Disorders
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 01, 2009