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Study of the Relationships Between Refractory Hypertension, Overweight/Obesity and Sleep Apnea Syndrome (RHOOSAS)

This study has been completed.
Sponsor:
Collaborator:
Fondation de Recherche sur l'Hypertension Arterielle, France
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00746902
First received: September 3, 2008
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

The purpose of the study is to investigate the links between blood pressure (BP), overweight or obesity, and sleep apnea syndrome (SAS), by studying a large cohort of subjects suffering from refractory hypertension.

Primary objective

  • To compare plasmatic leptin levels in patients suffering from refractory hypertension depending on whether or not they experience SAS.

Secondary objectives

  • To ascertain what determines the difference in plasmatic leptin concentrations in patients suffering from refractory hypertension depending on whether or not they experience SAS.
  • To characterise BP readings (from clinical and ambulatory (ABPM) measurements) in patients suffering from refractory hypertension depending on whether or not they experience SAS.
  • To characterise metabolic parameters (lipids, glycaemia, adiponectin) and sympathetic nervous system effectors (adrenaline, noradrenaline and metanephrines) in patients suffering from refractory hypertension depending on whether or not they experience SAS.
  • To characterise BP readings, metabolic parameters and sympathetic nervous system effectors in patients suffering from refractory hypertension according to the severity of the SAS (in those who experience this problem).
  • To study, in patients with both SAS and refractory hypertension, the impact of nasal continuous positive airway pressure (CPAP) treatment on BP readings, metabolic parameters and sympathetic nervous system effectors, by comparing those who are compliant with the CPAP regimen with those who are non-compliant.

Condition Intervention Phase
Refractory Hypertension
Device: nCPAP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Study of the Relationships Between Refractory Hypertension, Overweight/Obesity and Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • leptinemia [ Time Frame: inclusion visit, visit month 3, visit month 6 or 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BP readings (clinical and ABPM), metabolic parameters (lipids, glycaemia, adiponectin) and sympathetic nervous system effectors (adrenaline, noradrenaline and metanephrines). [ Time Frame: inclusion visit, visit month 3, visit month 6 or 9 ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: June 2008
Study Completion Date: September 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Arm 1: Active CPAP, a nasal continuous positive airway pressure
Device: nCPAP
Active nCPAP
Sham Comparator: 2
Arm 2 : Sham CPAP :Placebo/CPAP
Device: nCPAP
Active nCPAP

Detailed Description:

A number of factors predispose subjects to both hypertension and SAS, including overweight/obesity and hyperinsulinism. The pathogenesis of concomitant overweight/obesity and hypertension is multifactorial. There is an independent relationship between the degree of insulin resistance and the severity of SAS. A number of studies have suggested that hormones secreted by adipose tissue are involved in the pathogenesis of both hypertension and SAS, and overweight/obesity has been shown to be associated with elevated leptin levels coupled with reduced adiponectin levels.

Leptin is produced in adipose tissue and its levels rise with overweight/obesity due to peripheral resistance to its action. A number of studies have detected high leptinemia in both hypertensives and people suffering from SAS. Leptin may activate the sympathetic nervous system and promote SAS-related hypertension.

Adiponectin which is also produced in adipose tissue has beneficial activities, notably on atherogenesis. A relationship between hypertension and adiponectin has yet to be demonstrated.

Unlike leptin, adiponectin levels do not seem to be elevated in patients with SAS.

In terms of treatment, a number of studies have shown that CPAP has a positive effect on BP readings. Although this effect is modest, it is greater in subjects with SAS and rises with the severity of this condition. The effects of CPAP on plasmatic leptin and adiponectin levels are as yet unknown.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of either gender, of between 18 and 70
  • Suffering from refractory hypertension as defined by persistent clinical hypertension (> 140/90 mm Hg according to two different readings 24 hours apart) despite at least three classes of antihypertensive drugs (including a thiazide diuretic) at appropriate doses.
  • Recruited in the Cardiology Departments of the University Hospitals in Grenoble, Toulouse, Marseille and Poitiers, and in the Mozart Clinic in Paris.
  • Outpatients
  • Patients who have signed the consent form
  • Patients affiliated to or beneficiary of the social security system

Exclusion Criteria:

  • Failure to fulfil the inclusion criteria
  • Treated SAS, whatever the form of the treatment
  • Disease which might affect BP regulation, including Parkinson's disease, kidney or heart transplantation, dysautonomia, severe heart failure
  • Atrial fibrillation or regular extrasystole (> 10/minute)
  • Night- or shift-work
  • Pregnant and breast-feeding women
  • Patients under legal guardianship
  • Incarcerated patients or adults protected by the law
  • Hospitalised patients
  • Ongoing participation in another clinical research study
  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: NCT00746902

Locations
France
University Hospital
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Fondation de Recherche sur l'Hypertension Arterielle, France
Investigators
Principal Investigator: Jean-Philippe BAGUET, Professor University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00746902     History of Changes
Other Study ID Numbers: 0803, 2008-A00292-53
Study First Received: September 3, 2008
Last Updated: November 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Refractory hypertension
Obstructive sleep apnea syndrome
Obesity
Leptinemia
RHOOSAS study

Additional relevant MeSH terms:
Hypertension
Obesity
Overweight
Sleep Apnea Syndromes
Syndrome
Apnea
Body Weight
Cardiovascular Diseases
Disease
Dyssomnias
Nervous System Diseases
Nutrition Disorders
Overnutrition
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Sleep Disorders
Sleep Disorders, Intrinsic
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014