We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00409487
Recruitment Status : Completed
First Posted : December 11, 2006
Last Update Posted : September 8, 2010
Information provided by:
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Hypertension, Obstructive Sleep Apnea Device: Continuous positive airway pressure (CPAP) Drug: Valsartant treatment Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2006
Primary Completion Date : December 2006
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Valsartan
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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
Other Name: CPAP treatment
Drug: Valsartant treatment
8 weeks of Valsartant treatment (160 mg / day)
Experimental: 2
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
Other Name: CPAP treatment
Drug: Valsartant treatment
8 weeks of Valsartant treatment (160 mg / day)

Primary Outcome Measures :
  1. 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 Measures :
  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. [ Time Frame: 1 h ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409487

University Hospital Grenoble
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Principal Investigator: Jean-Louis JL PEPIN, ProfessorPhD University Hospital, Grenoble


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Grenoble, Délégation de la Recherche Clinique et de l'Innovation
ClinicalTrials.gov Identifier: NCT00409487     History of Changes
Other Study ID Numbers: 0617
First Posted: December 11, 2006    Key Record Dates
Last Update Posted: September 8, 2010
Last Verified: September 2010

Keywords provided by University Hospital, Grenoble:
obstructive sleep apnea
ambulatory bloop pressure monitoring

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action