This study has been designed to assess the effect of spironolactone as monotherapy on systolic and diastolic blood pressure in patients suffering from essential hypertension referred to the Health Heart House. In this randomized controlled clinical study, 40 people who are referred to Shiraz Heart House and suffer from essential hypertension according to ambulatory blood pressure holter monitoring have been selected. Inclusion criteria are: systolic blood pressure more than 135 mmhg or diastolic blood pressure more than 85 mmhg. Exclusion criteria are: serum creatinine more than 2 mg/dl؛ serum potassium more than 5 meq/l؛ renal or other endocrine diseases and diabetes. These persons have randomly been divided into experiment group (20 persons) receiving Spironolactone and control group (20 persons) who receive placebo. The experiment group has been given one tablet of Spironolactone daily for one month and the control group has been given one tablet of placebo daily for one month.
Also low salt and low fat diet will recommend to all patients.At the end, ambulatory blood pressure holter monitoring will be done again. Finally systolic and diastolic blood pressure before and after intervention will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502011525N6
Registration date:2015-03-14, 1393/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-14, 1393/12/23
Registrant information
Name
Mohammad Javad Zibaeenezhad
Name of organization / entity
Cardiovascular Research Center, Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1234 3529
Email address
zibaeem2@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Spironolactone as Monotherapy on Systolic and Diastolic Blood Pressure in Patients with Essential Hypertension
Public title
The Effect of Spironolactone in Treatment of Essential Hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion crireria: systolic blood pressure more than 135 mmhg; diastolic blood pressure more than 85 mmhg
Exclusion criteria: serum creatinine more than 2 mg/dl; serum potassium more than 5 meq/l; renal or other endocrine diseases; diabetes
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2014-12-14, 1393/09/23
Ethics committee reference number
CP-P-9354-5874
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Before intervention and 1 month after intervention