A comparative study on reduction in major cardiovascular events (pharmacological treatment versus diet control) in pre-hypertensive patient: a randomized control trial
Antihypertensive treatment in prehypertensive patients
Design
Two arms parallel-group randomized trial without blinding
Settings and conduct
We will divide 300 patients who are referred to the Imam Reza Cardiovascular Clinic into the treatment and control groups. The patients will then be followed and received the drugs for 18 months as previously mentioned above.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: all patients with Systolic blood pressure between 130-140 mmHg with atherosclerotic cardiovascular disease (ASCVD) equal to or more than 10%.
Exclusion criteria: the presence of diabetes mellitus (DM), cerebrovascular accident(CVA), Heart failure(HF), myocardial infarction(MI), before the entrance to the survey. Or patients received antihypertensive drugs due to any other reasons.
Intervention groups
Treatment group: these patients received an antihypertensive drug to control the blood pressure to less than 130/80 mmHg from the beginning. The Antihypertensive drug which is used in this clinical trial will be amlodipine 5 milligrams (manufactured by the Actover Pharmaceutical Company). This drug will be used once a day. The drug regimen will continue for 18 months.
Control group: low salt-low fat diet will be started for these patients. If their blood pressure rose above 140/90 during diet therapy, antihypertensive pharmacotherapy will be initiated for them with the same regimen as the treatment group.
Main outcome variables
Rates and differences in the incidence of myocardial infarction; rates and differences in the incidence of the acute coronary syndrome; rates and differences in the incidence of stroke; rates and differences in the incidence of heart failure; rates and differences in the incidence of mortality rate in the control and the treatment groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191002044961N1
Registration date:2019-12-03, 1398/09/12
Registration timing:registered_while_recruiting
Last update:2019-12-03, 1398/09/12
Update count:2
Registration date
2019-12-03, 1398/09/12
Registrant information
Name
Armin Attar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3227 9938
Email address
attarar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on reduction in major cardiovascular events (pharmacological treatment versus diet control) in pre-hypertensive patient: a randomized control trial
Public title
Antihypertensive treatment in prehypertensive patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Systolic blood presure (SBP)between 130-140 mmhg
Atherosclerosis cardiovascular disease (ASCVD) risk equal or more than 10 percent
Exclusion criteria:
Presence of Diabetes mellitus(DM) before starting survey
Presence of Cerebrovascular accident (CVA) before starting survey
Presence of heart failure(HF) before starting survey
Presence of myocardial infarction (MI) before starting survey
Patients recieved antihypertensive medications due to other reasons
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
We will use a random-permuted block for randomization :
We assign the different positions to the numbers 1 to 6 as follows:
1. AABB
2. ABAB
3. ABBA
4. BBAA
5. BABA
6. BAAB
(A contains patients from the treatment group and B contains patients from the control group)Then, we extract the numbers from the random numbers table and select any of the blocks assigned to these numbers, depending on which of these 6 numbers are selected. Blocks will get selected using the random numbers table until we have 36 blocks of 4letters.
Blinding (investigator's opinion)
Not 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 Shiraz University of Medical Sciences
Street address
Yas building, Abrishami street, Gas square, Shiraz town
City
Shiraz
Province
Fars
Postal code
7144833533
Approval date
2019-10-02, 1398/07/10
Ethics committee reference number
IR.SUMS.MED.REC.1398.420
Health conditions studied
1
Description of health condition studied
Prehypertension
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The incidence of myocardial infarction
Timepoint
Before starting the research. Then every month for the first 3 months then every 3 months till the end of the research which lasts 18 months totally.
Method of measurement
We will evaluate the incidence of myocardial infarction during this research.
2
Description
The incidence of acute coronary syndrome
Timepoint
Before starting the research. Then every month for the first 3 months then every 3 months till the end of the research which lasts 18 months totally.
Method of measurement
We will evaluate the incidence of acute coronary syndrome during this research.
3
Description
The incidence of cerebrovascular accident
Timepoint
Before starting the research. Then every month for the first 3 months then every 3 months till the end of the research which lasts 18 months totally.
Method of measurement
We will evaluate the incidence of cerebrovascular accident during this reaserch.
4
Description
The incidence of Heart failure
Timepoint
Before starting the research. Then every month for the first 3 months then every 3 months till the end of the research which lasts 18 months totally.
Method of measurement
We will evaluate the incidence of heart failure during this reaserch.
5
Description
The incidence of mortality rate due to cardiovascular events
Timepoint
Before starting the research. Then every month for the first 3 months then every 3 months till the end of the research which lasts 18 months totally.
Method of measurement
We wil evaluate the incidence of mortality rate due to cardiovascular events
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: these patients received an antihypertensive drug to control the blood pressure to less than 130/80 mmHg from the beginning. The antihypertensive drug used in this clinical trial will be amlodipine 5 milligrams (manufactured by the Actover Pharmaceutical Company). This drug will be administered once a day and the drug regimen will continue for 18 months.
Category
Prevention
2
Description
Control group: low salt-low fat diet will be started for these patients. If their blood pressure be more than 140/90 during diet therapy, antihypertensive pharmacotherapy will be initiated for them with the same regimen as the treatment group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza cardiovascular clinic
Full name of responsible person
Dr. Armin attar
Street address
Imam reza clinic, Namazi square
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۷۳۴
Phone
+98 71 3212 7001
Email
attarar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz town
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Armin Attar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Second floor, Namazi Hospital, Namazi Square, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 917 714 1797
Email
attarar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Armin Attar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Second floor, Namazi hospital, Namazi square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 917 714 1797
Email
attarar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Armin Attar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3227 9938
Fax
Email
attarar@sums.ac.ir
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