Protocol summary
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Study aim
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Antihypertensive treatment in prehypertensive patients
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Design
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Two arms parallel-group randomized trial without blinding
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Settings and conduct
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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 36 months as previously mentioned above.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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 36 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.
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Main outcome variables
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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
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Reason for update
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Respectfully, the patients have been followed for 36 months so far, and the duration of the trial was increased to 36 months.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191002044961N1
Registration date:
2019-12-03, 1398/09/12
Registration timing:
registered_while_recruiting
Last update:
2024-08-01, 1403/05/11
Update count:
2
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Registration date
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2019-12-03, 1398/09/12
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2019-11-22, 1398/09/01
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Expected recruitment end date
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2026-09-22, 1405/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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A comparative study on reduction in major cardiovascular events (pharmacological treatment versus diet control) in pre-hypertensive patient: a randomized control trial
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Public title
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Antihypertensive treatment in prehypertensive patients
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
All patients with Systolic blood presure (SBP)between 130-140 mmhg
Atherosclerosis cardiovascular disease (ASCVD) risk equal or more than 7.5 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
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
1620
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-02, 1398/07/10
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Ethics committee reference number
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IR.SUMS.MED.REC.1398.420
Health conditions studied
1
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Description of health condition studied
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Prehypertension
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The incidence of myocardial infarction
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Timepoint
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Before starting the research then every 6 months till the end of the research which lasts 36 months totally.
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Method of measurement
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We will evaluate the incidence of myocardial infarction during this research.
2
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Description
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The incidence of acute coronary syndrome
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Timepoint
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Before starting the research then every 6 months till the end of the research which lasts 36 months totally.
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Method of measurement
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We will evaluate the incidence of acute coronary syndrome during this research.
3
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Description
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The incidence of cerebrovascular accident
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Timepoint
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Before starting the research then every 6 months till the end of the research which lasts 36 months totally.
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Method of measurement
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We will evaluate the incidence of cerebrovascular accident during this reaserch.
4
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Description
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The incidence of Heart failure
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Timepoint
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Before starting the research then every 6 months till the end of the research which lasts 36 months totally.
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Method of measurement
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We will evaluate the incidence of heart failure during this reaserch.
5
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Description
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The incidence of mortality rate due to cardiovascular events
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Timepoint
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Every 6 months till the end of the research which lasts 36 months totally.
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Method of measurement
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We wil evaluate the incidence of mortality rate due to cardiovascular events
Intervention groups
1
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Description
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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 36 months.
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Category
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Prevention
2
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Description
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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
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available