Effect of 25 and 100 mg spironolactone on quality of life, ejection fraction and readmission in systolic heart failure patients with reduced ejection fraction in Imam Khomeini hospital in Ahvaz
Effect of 25 and 100 mg spironolactone on quality of life, ejection fraction and readmission in systolic heart failure patients with reduced ejection fraction in Imam Khomeini hospital in Ahvaz
Design
Clinical trial, parallel group trial with blinded, randomised outcome assessment, a phase 3 trial on 94 patients
Settings and conduct
The aim of the present study was to evaluate the effect of 25 and 100 mg spironolactone on quality of life, ejection fraction and readmission in systolic heart failure patients with reduced ejection fraction referred to Imam Khomeini Hospital in Ahvaz. Therapeutic effectiveness is measured by echocardiography, Minnesota Questionnaire and 6-MIN Walk test. This triple blind clinical trial is based on the protocol in which neither the participants, nor the researcher nor the data analyzer knows which treatment nor intervention participants are receiving until the clinical trial is over.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Acute systolic heart failure (EF <40)
A history of hospitalization in the last 6 months
Exclusion criteria:
Known contraindications for spironolactone or prior documented intolerance to an aldosterone receptor antagonist
Significant laboratory abnormalities (potassium ≥ 5.1 mmol)
Mental disorders suspected to interact with study outcome
Pregnant or nursing women
Significant renal dysfunction
Significant hypotension (lower than 90 mm Hg systolic or 60 mm Hg diastolic)
CRT or ICD
Intervention groups
1- 25 mg spironolactone group daily for 6 months
2- 100 mg spironolactone group daily for 6 months
Main outcome variables
Quality of life; Ejection fraction; Readmission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220404054403N1
Registration date:2022-05-30, 1401/03/09
Registration timing:prospective
Last update:2022-05-30, 1401/03/09
Update count:0
Registration date
2022-05-30, 1401/03/09
Registrant information
Name
hossein lalvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8037
Email address
hosseinlalvand69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-02, 1401/04/11
Expected recruitment end date
2022-10-08, 1401/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 25 and 100 mg spironolactone on quality of life, ejection fraction and readmission in systolic heart failure patients with reduced ejection fraction in Imam Khomeini hospital in Ahvaz
Public title
Effect of 25 and 100 mg spironolactone on quality of life, ejection fraction and readmission in systolic heart failure patients with reduced ejection fraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute systolic heart failure (EF <40)
A history of hospitalization in the last 6 months
Exclusion criteria:
Known contraindications for spironolactone or prior documented intolerance to an aldosterone receptor antagonist
Significant laboratory abnormalities (potassium ≥ 5.1 mmol)
Mental disorders suspected to interact with study outcome
Pregnant or nursing women
Significant renal dysfunction
Significant hypotension (lower than 90 mm Hg systolic or 60 mm Hg diastolic)
CRT or ICD
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, individual randomization with table of random numbers. Permuted randomization,Triple blind
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding is based on the protocol in in which neither the participants, nor researcher nor the data analyzer knows which treatment or intervention participants are receiving until the clinical trial is over.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan hospital
Street address
Farvardin Ave., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-03-08, 1400/12/17
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.003
Health conditions studied
1
Description of health condition studied
Systolic heart failure
ICD-10 code
I50.2
ICD-10 code description
Systolic (congestive) heart failure
Primary outcomes
1
Description
Ejection fraction
Timepoint
Before the intervention and 6 months after drug administration
Method of measurement
Echocardiography
2
Description
Quality of life
Timepoint
Before the intervention and 6 months after drug administration
Method of measurement
Minnesota Questionnaire
3
Description
Readmission
Timepoint
Before the intervention and 6 months after drug administration
Method of measurement
6 MIN Walk test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 mg spironolactone group daily for 6 months
Category
Treatment - Drugs
2
Description
Intervention group: 100 mg spironolactone group daily for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Hossein Lalvand
Street address
Azadegan Ave., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2922
Email
himam@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Hossein Lalvand
Street address
Farvardin Ave., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3320 4501
Email
golestanjpspital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Esfand Ave., Golestan Blvd., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hossein Lalvand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Esfand Ave., Golestan Blvd., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 8037
Email
hosseinlalvand69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hossein Lalvand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Esfand Ave., Golestan Blvd., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 8037
Email
hosseinlalvand69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hossein Lalvand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Esfand Ave., Golestan Blvd., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 8037
Email
hosseinlalvand69@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