Comparison between Eplerenone and Spironolactone in improving left ventricular systolic function among patients suffering from heart failure
Design
This single blind randomized clinical trial includes patients with symptomatic newly diagnosed heart failure without need to revascularization who take eplerenone or spironolactone, alternately in addition to taking usual heart failure medications. They undergo echocardiography at the beginning and then 6 months later and the alteration in echocardiographic variables will be compared between two groups.
Settings and conduct
This study is done on newly diagnosed symptomatic patients admitted to Fatemeh Zahra hospital in whom diagnosis of heart failure will be established based on the results of echocardiography.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Newly diagnosed symptomatic systolic heart failure patients; Exclusion criteria: Pregnancy, previous use of aldosterone antagonists, severe coronary artery disease with need to revascularization، hyperkalemia and serum creatinine more than 2mg/dl.
Intervention groups
Intervention group 1: These patients recieve oral spirinolactone tablet, 25 mg daily in addition to carvedilol and angiotensin converting enzyme inhibitor for 6 months, Intervention group 2: These patients recieve oral eplerenone tablet produced by Daroupakhsh company, 25 mg daily in addition to carvedilol and angiotensin converting enzyme inhibitor for 6 months.
Main outcome variables
The change in left ventricular systolic and diastolic function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130422013090N4
Registration date:2019-06-27, 1398/04/06
Registration timing:registered_while_recruiting
Last update:2019-06-27, 1398/04/06
Update count:0
Registration date
2019-06-27, 1398/04/06
Registrant information
Name
Maryam Nabati
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 4002
Email address
m.nabati@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-01, 1398/03/11
Expected recruitment end date
2020-05-31, 1399/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of spirinolactone and eplerenone on left ventricular systolic and diastolic function in patients with heart failure
Public title
Comparison between the effects of spironolactone and eplerenone in the treatment of heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
New onset symptomatic systolic heart failure with left ventricular systolic ejection fraction less than 40%
Exclusion criteria:
Pregnancy
Previous use of aldosterone antagonists
Severe coronary artery disease with need to revascularization
Age
From 20 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will alternately be administered spirinolactone or eplerenone
Blinding (investigator's opinion)
Single blinded
Blinding description
The cardiologist who performs echocardiographic exams does not know which patients recieve spirinolactone and which ones recieve eplerenone.
Placebo
Not used
Assignment
Parallel
Other design features
All patients take carvedilol and angiotensin converting enzyme inhibitors.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research Mazandaran University Of Medical Sciences, Moalem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4818936897
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR.MAZUMS.REC.1398.362
Health conditions studied
1
Description of health condition studied
Systolic heart failure
ICD-10 code
I50.1
ICD-10 code description
Left ventricular failure
Primary outcomes
1
Description
Left ventricular ejection fraction
Timepoint
at the beginning of the study and 6 months after starting treatment
Method of measurement
Echocardiography
2
Description
global longitudinal systolic strain
Timepoint
at the beginning of the study and 6 months after starting treatment
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: These patients recieve oral spirinolactone tablet, 25 mg daily in addition to carvedilol and angiotensin converting enzyme inhibitor for 6 months.
Category
Treatment - Drugs
2
Description
Intervention group 2: These patients recieve oral eplerenone tablet produced by Daroupakhsh company, 25 mg daily in addition to carvedilol and angiotensin converting enzyme inhibitor for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Fatemeh Zahra hospital
Full name of responsible person
Maryam Nabati
Street address
Sari Training Building, Fatemeh Zahra Hospital, Artesh Blvd, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4818936897
Phone
+98 11 3332 4002
Email
dr.mr.nabati@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Mazandaran University of Medical Sciences, Valiasr Highway, Juibar Crossroad, Imam Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
33543764
Phone
+98 11 3354 3764
Email
aeedi_m_2001@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Nabati
Position
Associate professor of cardiology
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Building Research Council of Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3448 4874
Email
dr.mr.nabati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Nabati
Position
Associate professor of cardiology
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Building Research Council of Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3448 4874
Email
dr.mr.nabati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Nabati
Position
Associate professor of cardiology
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Building Research Council of Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3448 4874
Email
dr.mr.nabati@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available