The aim of this study is to compare continuous positive airway pressure with standard treatment in patients with refractory hypertension and sever obstructive sleep apnea (loss of respiratory flow to 50% for more than 10 times/hour and 4% reduction in O2 saturation in pulse oximetry). Patients will be randomly divided to control(losartan 25mg/bid, triamteren-H 50mg/day, amlodipin 5mg/bid, Acetazolamid 250mg/day, fluoxetine 20mg/day) and intervention (losartan 25mg/bid, triamteren-H 50mg/day, amlodipin 5mg/bid and continuous positive airway pressure)groups. All patients will be treated 4 weeks and systolic and diastolic blood pressure will be evaluated 3 times weekly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108167346N1
Registration date:2011-12-19, 1390/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-19, 1390/09/28
Registrant information
Name
Bahareh Bayat
Name of organization / entity
Arak Univercity of Medical Sences
Country
Iran (Islamic Republic of)
Phone
+98 86 1223 9264
Email address
dr.bbayat@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2011-08-21, 1390/05/30
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of continuous positive airway pressure in the treatment of refractory hypertension in patients with sever obstructive sleep apnea
Public title
Effect of continuous positive airway pressure in the treatment of refractory hypertension in patients with sever obstructive sleep apnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age:40-80; refractory hypertension and severe obstructive sleep apnea(AHI>15)
exclusion criteria:central apnea;current severe respiratory disease;functional class:III, IV;pregnancy;secondary hypetension;history of treatment by continuous positive airway pressure.
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Arak, Iran
City
Arak
Postal code
Approval date
2011-07-27, 1390/05/05
Ethics committee reference number
90-111-2
Health conditions studied
1
Description of health condition studied
High blood pressure
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
2
Description of health condition studied
Sleep apnoea
ICD-10 code
G47.3
ICD-10 code description
Sleep apnoea
Primary outcomes
1
Description
Blood Pressure
Timepoint
3 times a week
Method of measurement
mmHg(by mercury barometer)
Secondary outcomes
1
Description
Heart rate
Timepoint
3 times/week
Method of measurement
Beat/min
Intervention groups
1
Description
Control group: losartan 25mg/bid +Triamterene-H 50mg/day + Amlodipine 5mg/bid + Acetazolamid 250mg/day and Fluoxetine 20mg/day
Category
Treatment - Drugs
2
Description
Intervention group: Losartan 25mg/bid + Triamterene-H 50mg/day + Amlodipine 5mg/bid + Nasal CPAP(every night for 4 weeks)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Street address
Amiralmomenin hospital, Arak, Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Saeed Changizi Ashtiyani
Street address
Office of Vice Chancellor for Research of Arak University of Medical Sciences, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Bahare Bayat
Position
MD
Other areas of specialty/work
Street address
Amiralmomenin hospital, Arak, Iran
City
Arak
Postal code
Phone
+98 86 1223 5605
Fax
Email
dr.bbayat@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Reza Shahmirzaiee
Position
MD Cardiologist
Other areas of specialty/work
Street address
Amiralmomenin hospital, Arak University of Medical Sciences, Arak, Iran
City
Arak
Postal code
Phone
+98 86 1417 3505
Fax
Email
dr.bbayat@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Bahare Bayat
Position
MD
Other areas of specialty/work
Street address
Amiralmomenin hospital, Arak, Iran Arak
City
Arak
Postal code
Phone
+98 86 1223 5605
Fax
Email
dr.bbayat@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)