Determining the onset of losartan systemic administration effect on intraocular pressure in hypertensive patients refer to Feiz hospital in 1400
Design
Randomized, single group, 42 patients, not blinded, phase 2
Settings and conduct
Cardiologist selects hypertensive patients refer to cardiology clinic of Feiz hospital, Esfahan, that have indication of losartan therapy, then refer to glaucoma clinic of Feiz hospital for intraocular pressure measurement by ophthalmologist on beginning of study then follow up after 1 and 3 month later.
Participants/Inclusion and exclusion criteria
Patients who are a new case of HTN under treatment with losartan, age between 30-70, that has no comorbidity disease and no glaucoma and no eye diseases
Intervention groups
Intervention group: losartan systemic administration and measuring intraocular pressure in hypertensive patients before, one month, and three months after therapy.
Main outcome variables
Reduce intraocular pressure after losartan therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210125050134N1
Registration date:2021-12-21, 1400/09/30
Registration timing:retrospective
Last update:2021-12-21, 1400/09/30
Update count:0
Registration date
2021-12-21, 1400/09/30
Registrant information
Name
Ali Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3445 2703
Email address
a_salehi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-23, 1400/04/02
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of onset of losartan systemic administration on intraocular pressure in hypertensive patients
Public title
Effect of losartan on intraocular pressure changes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
New HTN cases
Monotherapy with losartan
Exclusion criteria:
Glaucoma
Eye disease
Comorbidity diseae exept HTN
Myopia and hyperopia
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
2
Right eye, Left eye
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of Medical Sciences
Street address
Feiz hospital, Modares St., Qhods sq.
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۹۶۴۴۸۷۴
Approval date
2021-01-04, 1399/10/15
Ethics committee reference number
IR.MUI.MED.REC.1399.896
Health conditions studied
1
Description of health condition studied
Intraocular pressure changing in hypertensive patients with normal IOP
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intraocular pressure changing during 1 and 3 months
Timepoint
0 , 1month ,3months
Method of measurement
Tonometry , Goldman Slit Lamp Tonometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: tab. losartan 50mg administer daily for 3 month and follow up in single group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Afagh Ekramnia
Street address
Feiz hospital. Modaress St. Ghods sq.
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۹۶۴۸۷۴
Phone
+98 31 3446 7010
Email
afagh.ek@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo Javanmardi
Street address
Feiz hospital, Modaress st, Ghods sq.
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۹۶۴۴۸۷۴
Phone
+98 31 3446 7010
Email
afagh.ek@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Ali Salehi
Position
Associate Professor of Retina & Vitreous
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Feiz hospital, Modaress St., Ghods sq.
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۹۶۴۴۸۷۴
Phone
+98 31 3446 7010
Email
a_salehi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Ali Salehi
Position
Associate Professor of Retina and viterous
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Feiz hospital, Moddares St., qods sq.
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۹۶۴۴۸۷۴
Phone
+98 31 3446 7010
Email
a_salehi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afagh Ekramnia
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Feiz hosspital, Modaress St., Gods sq.
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۹۶۴۴۸۷۴
Phone
+98 31 3446 7010
Email
afagh.ek@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available