Back to results

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

Primary Purpose

Hypertension,, Obstructive Sleep Apnea

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Continuous positive airway pressure (CPAP)

Valsartant treatment

About this trial

This is an interventional treatment trial for Hypertension, focused on measuring obstructive sleep apnea, hypertension, ambulatory bloop pressure monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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.

Full Information

NCT ID

NCT00409487

First Posted

December 8, 2006

Last Updated

September 7, 2010

Sponsor

University Hospital, Grenoble

1. Study Identification

Unique Protocol Identification Number

NCT00409487

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Grenoble

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension,, Obstructive Sleep Apnea

Keywords

obstructive sleep apnea, hypertension, ambulatory bloop pressure monitoring

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Continuous positive airway pressure (CPAP)

Other Intervention Name(s)

CPAP treatment

Intervention Description

8 weeks of CPAP

Intervention Type

Drug

Intervention Name(s)

Valsartant treatment

Intervention Description

8 weeks of Valsartant treatment (160 mg / day)

Primary Outcome Measure Information:

Title

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

Time Frame

24 h

Secondary Outcome Measure Information:

Title

Time Frame

1 h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Louis JL PEPIN, ProfessorPhD

Organizational Affiliation

University Hospital, Grenoble

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Grenoble

City

Grenoble

ZIP/Postal Code

38000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

12748199

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. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14. Erratum In: JAMA. 2003 Jul 9;290(2):197.

Results Reference

background

PubMed Identifier

15716692

Citation

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.

Results Reference

background

PubMed Identifier

16331122

Citation

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.

Results Reference

background

PubMed Identifier

11812555

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.

Results Reference

background

PubMed Identifier

12515745

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.

Results Reference

background

PubMed Identifier

10806134

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. doi: 10.1164/ajrccm.161.5.9909024.

Results Reference

background

PubMed Identifier

16269974

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. doi: 10.1097/01.hjh.0000188734.98463.82.

Results Reference

background

PubMed Identifier

15126927

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. doi: 10.1097/00004872-200404000-00028.

Results Reference

background

PubMed Identifier

12888174

Citation

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.

Results Reference

background

PubMed Identifier

20522795

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs