Effect of Carvedilole and combination of Terazosin plus Enalapril on blood pressure and urinary symptoms among patients with Hypertension and Benign Prostatic Hyperplasia
1-comparative study of carvedilol with combination of terazosin and enalaprilon on blood pressure and obstructive urinary symptoms in patients with moderate HTN and BPH.
2-comparative study of carvedilol with combination of terazosin and enalaprilon on maximum Urine flow rate (Qmax), serum PSA and post voiding residual (PVR) in patients with moderate HTN and BPH.
Design
Randomized, double-blind, crossover clinical trial in which 40 eligible patients will participate
Settings and conduct
This study will be conducted at urology clinic of Imam Reza hospital, Patients in 2 groups were receive the carvedilol (starting dose 12.5 mg/d) and placebo, other group terazosin 5 mg and enalapril (10 mg/d). Full clinical evaluations were performed during 4 visits: at baseline, after 12 W of treatment, at the end of the washout period, and after the next 12 W of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Moderate hypertension according to the European Society of Hypertension guidelines, defined as diastolic blood pressure (BP) between 90 and 99 mm Hg or systolic BP between 140 and 159 mm Hg (or both)]; men over than 40 years with BPH and persisted LUTS during the last 6 months.
Non-inclusion criteria: previous prostate surgery; prostate malignancy; Uncontrolled or urgency Hypertension; Use of other drugs during this study, history of using anti-hypertensive and prostate drugs.
Intervention groups
Intervention group 1: treatment with carvedilol and placebo, then 12 weeks wash out period and after that treatment with Terazosin and Enalapril.
Intervention group 2: treatment with Terazosin and Enalapril, then 12 weeks wash out period and after that treatment with carvedilol and placebo.
Main outcome variables
Q max(maximum urine flow in uroflowmetry)؛
PVR (post void residue)؛
IPSS score (international prostate symptoms score)؛
Serum PSA (prostate specific antigen) ؛
systolic and diastolic blood pressure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181128041777N1
Registration date:2019-03-14, 1397/12/23
Registration timing:retrospective
Last update:2019-03-14, 1397/12/23
Update count:0
Registration date
2019-03-14, 1397/12/23
Registrant information
Name
Nooriyeh Dalir akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 9633
Email address
info@imamreza.tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2018-12-29, 1397/10/08
Actual recruitment start date
2018-09-21, 1397/06/30
Actual recruitment end date
2018-10-02, 1397/07/10
Trial completion date
2018-10-22, 1397/07/30
Scientific title
Effect of Carvedilole and combination of Terazosin plus Enalapril on blood pressure and urinary symptoms among patients with Hypertension and Benign Prostatic Hyperplasia
Public title
Effect of Carvedilole compared to Terazosin plus Enalapril in treatment of Hypertension and benign prostatic hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate hypertension (according European guide line blood pressure between 140-159 in systolic and 90-99 in diastolic)
Men above 40 years with benign prostatic hyperplasia that diagnosis with permanent LUTS during the last 6 months ,physical examination, ultrasonography and serum PSA
Exclusion criteria:
History of using alfa blockers during the last 6 months
history of uncontrolled or malignant urgency HTN
history of using anti hypertensive and prostate drugs
history of prostate cancer
history of prostate surgery
Age
From 40 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
block, simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
central building of Tabriz University of Medical Sciences, Golgasht avenue, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5156954567
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.TBZMED.REC.1397.604
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
2
Description of health condition studied
Benign prostate hyperplasia
ICD-10 code
N40.1
ICD-10 code description
Enlarged prostate with lower urinary tract symptoms
Primary outcomes
1
Description
Q max: Maximum urinary flow rate show in uroflowmetry
Timepoint
in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that.
Method of measurement
uroflowmetry
Secondary outcomes
1
Description
PVR :Post Voiding Residual
Timepoint
in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that.
Method of measurement
Sonography
2
Description
IPSS : international prostate symptom score
Timepoint
in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that.
Method of measurement
International prostate symptom score questionnaire
3
Description
PSA : prostate specific antigen
Timepoint
in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that.
Method of measurement
Blood test
4
Description
Systolic blood pressure
Timepoint
in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that.
Method of measurement
mercury manometer
5
Description
Diastolic blood pressure
Timepoint
in 4 time: before treatment. after carvedilol. before enalapril and terazosin and after that.
Method of measurement
mercury manometer
Intervention groups
1
Description
Intervention group 1: After random allocation in 2 groups, first group was treated with Carvedilol, produced by SOHA company, 12.5 mg (Max 25 mg) and Blood pressure was kept in normal range (120 over 80 mmHg). Tab VitB complex-DP was used as placebo. Prostate examination, recording urinary symptoms and blood pressure control were done every month. Treatment period was 12 weeks and after that there was a 12-week wash out period with blood pressure checking every month. Then this group was treated with terazosin produced by ARYA company, 5 mg up to 20 mg and enalapril produced by SOBHAN company, 2.5 mg max 20 mg to achieve normal blood pressure. Examinations and blood pressure recording were done every month. Treatment periods were 12 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2 received terazosin, produced by ARYA company, 5 mg up to 20 mg and enalapril, produced by SOBHAN company, 2.5 mg max 20 mg to control blood pressure in normal range. Treatment period was 12 weeks and after that there was a 12-week wash out period with blood pressure checking every month. Then this group received carvedilol, produced by SOHA company, 12.5 mg max 25 mg with Vitamin-B complex DP as placebo. Blood pressure and prostate examination was done each month. Treatment period was 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza hospital
Full name of responsible person
Nooriyeh Dalir Akbari
Street address
Golgasht Avenue, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5156954567
Phone
+98 41 3335 9633
Fax
+98 41 3335 9680
Email
dr.neda67.nd@gmail.com
Web page address
https://www.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza rashidi
Street address
Central building of Tabriz University of Medical Sciences, Golgasht avenue, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5156954567
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
dr.neda67.nd@gmail.com
Web page address
https://www.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nooriyeh Dalir Akbari
Position
Medical resident
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shahriar Ave. Golcar Blvd. Aref Town.No 15
City
Tabriz
Province
East Azarbaijan
Postal code
5156954567
Phone
+98 41 3335 9633
Fax
Email
info@imamreza.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nooriyeh Dalir akbari
Position
Medical resident
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No 15, Aref Town, GolKar Blvd, Shahriar street
City
Tabriz
Province
East Azarbaijan
Postal code
5156954567
Phone
+98 41 3335 9633
Fax
Email
info@imamreza.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nooriyeh Dalir akbari
Position
Medical resident
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No 15, Aref Town, GolKar Blvd, Shahriar street
City
Tabriz
Province
East Azarbaijan
Postal code
5156954567
Phone
+98 41 3335 9633
Fax
Email
info@imamreza.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data without patients' name can be accessible through email.
When the data will become available and for how long
accessible after publication on 2019
To whom data/document is available
all researchers
Under which criteria data/document could be used
after written permission of author
From where data/document is obtainable
Tabriz university of medical science
http://pazhoohan.tbzmed.ac.ir
What processes are involved for a request to access data/document
accessible after email on Tabriz university of medical science site