Protocol summary

Study aim
Comparison and evaluation of the effectiveness of oral captopril and oral hydrochlorothiazide in the treatment of urgency hypertensive patients
Design
The clinical trial has two intervention groups in parallel, double-blind, with block randomization method on 70 samples.
Settings and conduct
This study will be performed as a double-blind clinical trial (patient and interventionist) in patients with urgency hypertension who will be randomly divided into two equal groups of 35 patients in Khatam Al-Anbia Hospital in Shahroud.
Participants/Inclusion and exclusion criteria
Admission requirements: Refer to the hospital emergency department of patients with known hypertension with a blood pressure of 160/90 mm Hg or more and patients with the New-onset Hpertension with blood pressure of 180/110 mm Hg or more without organ damage (urgency blood pressure) in patients aged 18 to 65 years Exclusion criteria: 1. Patients who need intravenous drugs to control blood pressure 2. Patients with myocardial infarction presenting with acute chest pain 3. Patients with severe renal or hepatic insufficiency 4. Papillary edema 5. Pulmonary edema 6. Decreased level of consciousness and cerebrovascular accidents 7. Pregnant patients
Intervention groups
Patients will be divided into two groups: A (taking captopril 25 mg orally) and group B (taking 25 mg hydrochlorothiazide orally).
Main outcome variables
systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200722048172N1
Registration date: 2020-08-10, 1399/05/20
Registration timing: registered_while_recruiting

Last update: 2020-08-10, 1399/05/20
Update count: 0
Registration date
2020-08-10, 1399/05/20
Registrant information
Name
MOHAMMAD AMIN QAREHKHANI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3572 6109
Email address
maq1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-21, 1398/06/30
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison and evaluation of the effectiveness of oral captopril and oral hydrochlorothiazide in the treatment of urgency hypertensive patients
Public title
Comparison and evaluation of the effectiveness of oral captopril and oral hydrochlorothiazide in the treatment of urgency hypertensive patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with known hypertension with a blood pressure of 160/90 mm Hg or more and patients with the new-onset sever hypertention with a blood pressure of 180/110 mm Hg or more without organ damage (urgency) will be included in the study if satisfied. Patients between the ages of 18 and 65 will be included in the study.
Exclusion criteria:
Patients who need intravenous drugs to control their blood pressure or other blood pressure medications for different reasons. Patients who need high dose of ACEIs or ARBs (> 50 mg/d Captopril, > 10 mg/d Enalapril, > 5 g/dLisinopril, > 50 mg/d Losartan, > 80 mg/d Valsartan),to control their blood pressure. Patients with myocardial infarction presenting with acute chest pain. Patients with severe renal or hepatic failure,anuria, papillaryedema, pulmonary edema, loss of consciousness, seizure,aortic dissection, or bilateral renal artery stenosis; pregnantpatients, patients with a history of overt allergy or angioedemawith ACEIs, Allergy to penicillins and sulfonamides.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
If the inclusion criteria are met and blood pressure does not decrease after 20 minutes of rest, after randomization of the block and placing patients in two groups A and B in order to eliminate the bias caused by patient awareness and health care (which task The capsule is given to the patient and the measurements and information are recorded from the beginning of the study) depending on the type of treatment received and its possible effect on the results, the study will be performed blindly, so captopril and hydrochlorothiazide tablets in exactly the same capsules They are placed so that the patient and the health care provider are not informed about the type of medicine received.
Blinding (investigator's opinion)
Double blinded
Blinding description
If the inclusion criteria are met and after 20 minutes of rest and taking 2 equal blood presses 5 minutes apart, patients are randomly divided into two equal groups by block randomization. The drug is then given by a special clinical caregiver who is not aware of the type of drug to the study participant who is also not an absolute drug to be swallowed with water in the standard way and then in 10, 20, 30, 45, 60, 90, 120, 180 minutes After administration of the drug, systolic, diastolic blood pressure and heart rate in the sitting physical position will be taken by the same clinical caregiver.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Semnan Branch
Street address
Islamic Azad University of Semnan Complex ,Daneshgahi Town Semnan
City
Semnan
Province
Semnan
Postal code
37111-35131
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
ir.iau.semnan.rec.1398.022

Health conditions studied

1

Description of health condition studied
Urgency Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Systolic Blood Pressure
Timepoint
In 10, 20, 30, 45, 60, 90, 120, 180 minutes after drug administration
Method of measurement
With a hand pressure guage and with ascale of millimeters of mercury

2

Description
Diastolic Blood Pressure
Timepoint
In 10, 20, 30, 45, 60, 90, 120, 180 minutes after drug administration
Method of measurement
With a hand pressure guage and with ascale of millimeters of mercury

3

Description
Mean Blood Pressure
Timepoint
10, 20, 30, 45, 60, 90, 120, 180 minutes after drug administration
Method of measurement
After measuring systolic and diastolic blood pressure its measured with the sum of twice the diastolic blood pressure and systolic blood pressure divided by three (3 / (2DBP + SBP)) will be calculated.

4

Description
Heart Rate
Timepoint
10, 20, 30, 45, 60, 90, 120, 180 minutes after drug administration
Method of measurement
It will be obtained by counting the number of pulses per minute.

Secondary outcomes

1

Description
Satisfaction rate
Timepoint
At intervals and ends of measurements
Method of measurement
Questionnaire

2

Description
Drug side effects
Timepoint
At intervals and ends of measurements
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group:Taking captopril 25 mg orally and in a single dose
Category
Treatment - Drugs

2

Description
Intervention group:Take hydrochlorothiazide 25 mg orally and in a single dose
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam al-Anbia Hospital
Full name of responsible person
Hossein Haratipour
Street address
Khatam Al-Anbia Hospital., University Blvd
City
Shahroud
Province
Semnan
Postal code
3614871151
Phone
+98 23 3233 9661
Fax
+98 23 3233 1876
Email
khatam@shahrood.ac.ir
Web page address
http://khatam.iau-shahrood.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behrouz Yahyaei
Street address
Khatam Al-Anbia Hospital., University Blvd
City
Shahroud
Province
Semnan
Postal code
3614871151
Phone
+98 23 3233 9661
Email
maq1372@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mohammad Amin Qarehkhani
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nasrin Razavianzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Khatam Al-Anbia Hospital., University Blvd
City
Shahroud
Province
Semnan
Postal code
3614871151
Phone
+98 23 3233 9661
Email
nasrinrazavianzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nasrin Nazavianzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Khatam Al-Anbia Hospital., University Blvd
City
Shahroud
Province
Semnan
Postal code
3614871151
Phone
+98 23 3233 9661
Email
nasrinrazavianzadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Amin Qarehkhani
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
Cardiology
Street address
No.11,Rajaei Avenue., Daneshjoo Blvd., Azadshahr town
City
Azadshahr
Province
Golestan
Postal code
4961786161
Phone
009835726109
Email
maq1372@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
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