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

NCT00746902 | Completed Phase 3

• 2 other identifiers: 08032008-A00292-53
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Hypertension

Keywords

Refractory hypertension; Obstructive sleep apnea syndrome; Obesity; Leptinemia; RHOOSAS study

Outcome Measures

Primary Outcomes (1)

• leptinemia

  inclusion visit, visit month 3, visit month 6 or 9

Secondary Outcomes (1)

• BP readings (clinical and ABPM), metabolic parameters (lipids, glycaemia, adiponectin) and sympathetic nervous system effectors (adrenaline, noradrenaline and metanephrines).

  inclusion visit, visit month 3, visit month 6 or 9

Study Arms (2)

1

ACTIVE COMPARATOR

Arm 1: Active CPAP, a nasal continuous positive airway pressure

Device: nCPAP

2

SHAM COMPARATOR

Arm 2 : Sham CPAP :Placebo/CPAP

Device: nCPAP

Interventions

nCPAP DEVICE

Active nCPAP

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Fondation de Recherche sur l'Hypertension Artérielle: collaborator

Study Sites (1)

University Hospital

Grenoble, France

Location

Related Publications (1)

• Joyeux-Faure M, Baguet JP, Barone-Rochette G, Faure P, Sosner P, Mounier-Vehier C, Levy P, Tamisier R, Pepin JL. Continuous Positive Airway Pressure Reduces Night-Time Blood Pressure and Heart Rate in Patients With Obstructive Sleep Apnea and Resistant Hypertension: The RHOOSAS Randomized Controlled Trial. Front Neurol. 2018 May 8;9:318. doi: 10.3389/fneur.2018.00318. eCollection 2018.

  PMID: 29867728 DERIVED

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Philippe BAGUET, Professor

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2014
• Last Updated: November 7, 2014

Record last verified: 2014-11

Locations

FR (1)