Study of the Relationships Between Refractory Hypertensio... | NCT00746902

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

NCT00746902

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Nov 7, 2014Estimated

Enrollment

62Actual

Phase

Phase 3

Conditions

Refractory Hypertension

Interventions

nCPAP

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-A00292-53	Registry Identifier	ID RCB

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2013Actual

Completion Date

Sep 2014Actual

First Submitted Date

Sep 3, 2008

First Submission Date that Met QC Criteria

Sep 3, 2008

First Posted Date

Sep 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2014

Last Update Posted Date

Nov 7, 2014Estimated

Name	Class
Fondation de Recherche sur l'Hypertension Artérielle	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
nCPAP	Device	Active nCPAP	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
leptinemia		inclusion visit, visit month 3, visit month 6 or 9

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jean-Philippe BAGUET, Professor	University Hospital, Grenoble	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29867728	Derived	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.

ID	Term
D006973	Hypertension
D020181	Sleep Apnea, Obstructive
D009765	Obesity

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012891	Sleep Apnea Syndromes
D001049	Apnea