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

September 7, 2010 updated by: University Hospital, Grenoble

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • CPAP treatment
Drug: Valsartant treatment
8 weeks of Valsartant treatment (160 mg / day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), 8 weeks, 12 weeks, and 20 weeks
Time Frame: 24 h
24 h

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Louis JL PEPIN, ProfessorPhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 8, 2006

First Submitted That Met QC Criteria

December 8, 2006

First Posted (Estimate)

December 11, 2006

Study Record Updates

Last Update Posted (Estimate)

September 8, 2010

Last Update Submitted That Met QC Criteria

September 7, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0617

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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