Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea (BOSAS)

May 20, 2014 updated by: University Hospital, Grenoble

Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan

The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.

The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

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, 38043
        • CHU de 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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented obstructive sleep apnea
  • with untreated mild systemic hypertension

Exclusion Criteria:

  • pregnancy or lactation
  • daytime alveolar hypoventilation
  • severe arterial hypertension (systolic pressure > 180 mmHg; diastolic pressure > 110 mmHg)
  • treatment with anti-hypertensive drugs
  • cardiovascular disorder other than mild hypertension
  • severe daytime sleepiness (score on the EPWORTH sleepiness scale ≥15) or at-risk occupation
  • contra-indication to nCPAP treatment
  • known allergy to bosentan
  • active treatment with a drug whose efficacy is reduced by cytochromes P450, 2C9, 3A4 and2C19 isoenzyme activation
  • active treatment with a drug acting on systemic arterial blood pressure or endothelial function
  • liver or kidney dysfunction

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Device: nasal continuous positive airway pressure (CPAP)
Daily application throughout sleep for 4 weeks
EXPERIMENTAL: 1
Drug: bosentan
62.5 mg b.i.d for 4 weeks
Other Names:
  • TRACLEER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24 hour mean diastolic blood pressure
Time Frame: before and after each treatment completion (4 weeks)
before and after each treatment completion (4 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Peripheral Arterial Tonometry measure
Time Frame: before and after each treatment completion (4 weeks)
before and after each treatment completion (4 weeks)
mean 24 hour systemic systolic blood pressure
Time Frame: before and after each treatment completion (4 weeks)
before and after each treatment completion (4 weeks)
mean 24 hour nocturnal blood pressure
Time Frame: before and after each treatment completion (4 weeks)
before and after each treatment completion (4 weeks)
carotid Intima Media Thickness
Time Frame: before and after each treatment completion (4 weeks)
before and after each treatment completion (4 weeks)
Circulating inflammation markers (RANTES, MCP-1, TNF-alpha, INF-gamma, IL-6, IL-10 and TGF-gamma
Time Frame: before and after each treatment completion (4 weeks)
before and after each treatment completion (4 weeks)
Circulating Big ET1 and ET1 levels
Time Frame: before and after each treatment completion (4 weeks)
before and after each treatment completion (4 weeks)

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Actelion

Investigators

  • Principal Investigator: Sandrine H Launois, MD PhD, University Hospital, Grenoble

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, 2007

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 22, 2008

First Posted (ESTIMATE)

October 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0722
  • 2007-005333-11 (REGISTRY: EudraCT number)

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.

Clinical Trials on Hypertension

Clinical Trials on bosentan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe