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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00409487
First received: December 8, 2006
Last updated: September 7, 2010
Last verified: September 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


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
Study Completion Date: May 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other Name: Valsartant treatment
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)
Other Name: Valsartant 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).

  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
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, see Learn About Clinical Studies.

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

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

Publications:

Additional 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
Study First Received: December 8, 2006
Last Updated: September 7, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Hypertension
Apnea
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
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014