Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409487
Status:
COMPLETED
Last Update Posted:
2010-09-08
First Post:
2006-12-08
Brief Title:
Effects of Continuous Positive Airway Pressure and Valsartan Treatments on Arterial Blood Pressure in OSAS Patients
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Comparative Study of Effect of Valsartan 160mg Treatment Versus Continuous Positive Airway Pressure on Arterial Blood Pressure in Patients Who Have an Obstructive Sleep Apnea Syndrome and a Weak or Moderate Hypertension
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VALSAS
Brief Summary:
The main objective of the study is to compare the decrease of mean arterial blood pressure over 24 hours in patients having obstructive sleep apnea syndrome and weak or moderate hypertension treated by Valsartan 160mg per day versus continuous Positive Airway Pressure
Detailed Description:
It is now well known that cardiovascular risks are increased in patients with obstructive sleep apnea syndrome OSAS Also a link has already been demonstrated between OSAS and hypertension
Nowadays the most efficient treatment of the OSAS is the continuous Positive Airway Pressure cPAP Several studies have also shown that cPAP could reduce arterial blood pressure of about 33 mmHg in OSAS patients Unfortunately 40 of the patients either refuse being treated by cPAP or give up treatment In parallel alternative medications are proposed to patients with moderate OSAS and hypertension in order to decrease their cardiovascular risks A study led on rats has shown the superiority of the beta adrenergic blocking agents in the decrease of hypertension in OSAS patients
Our study has also the objective to compare the effects of Valsartan and cPAP on hypertension in OSAS patients Those one will be randomized either in the group treatment by Valsartan and then by cPAP or in the group treatment by cPAP and then Valsartan cross-over study
Nowadays the most efficient treatment of the OSAS is the continuous Positive Airway Pressure cPAP Several studies have also shown that cPAP could reduce arterial blood pressure of about 33 mmHg in OSAS patients Unfortunately 40 of the patients either refuse being treated by cPAP or give up treatment In parallel alternative medications are proposed to patients with moderate OSAS and hypertension in order to decrease their cardiovascular risks A study led on rats has shown the superiority of the beta adrenergic blocking agents in the decrease of hypertension in OSAS patients
Our study has also the objective to compare the effects of Valsartan and cPAP on hypertension in OSAS patients Those one will be randomized either in the group treatment by Valsartan and then by cPAP or in the group treatment by cPAP and then Valsartan cross-over study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None