Refractory Hypertension Clinical Trial
Official 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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 |