Refractory Hypertension Clinical Trial
— RHOOSASOfficial title:
Study of the Relationships Between Refractory Hypertension, Overweight/Obesity and Sleep Apnea Syndrome
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | September 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | Fondation de Recherche sur l'Hypertension Arterielle, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | leptinemia | inclusion visit, visit month 3, visit month 6 or 9 | No | |
Secondary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04213963 -
Prospective Study on Primary Aldosteronism in Resistant Hypertension
|
||
Completed |
NCT00812695 -
Effects of Continuous Positive Airway Pressure (CPAP) in Patients With Resistant Hypertension and Obstructive Sleep Apnea (OSA)
|
Phase 3 | |
Terminated |
NCT00899977 -
TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension
|
Phase 1/Phase 2 | |
Completed |
NCT03223272 -
Mechanisms of Refractory Hypertension (Reserpine)
|
Phase 2 | |
Completed |
NCT01656096 -
Renal Sympathetic Denervation in Mild Refractory Hypertension
|
Phase 4 |