The study of the effects of amlodipine addition to combination therapy of Deferiprone and Deferoxamine to reduce cardiac iron overload measurable with T2*MRI in thalassemic patients
The effect of adding amlodipine to combination therapy of desferal and deferiprone on reducing cardiac iron overload measurable by T2 * MRI
Design
This study is a randomized double-blind clinical trial.
In this study, 30 patients with thalassemia major who are over 5 years old and have been receiving blood for at least 2 years on a regular basis were enrolled after informed consent.
Patients will be randomly divided into two equal groups. In the intervention group, patients will receive amlodipine at a dose of 5 and 2.5 mg with chelator and in the control group will receive chelator only for one year.
Settings and conduct
This study is a randomized double blind clinical trial on all thalassemia major patients referred to Amir Kabir Hospital in Arak. And statistics experts who analyze the data are blind to the groups, and only the hematologist and interns in charge of the study are aware of the study groups.
Participants/Inclusion and exclusion criteria
In this study, 30 patients with thalassemia major who are over 5 years old and have been receiving blood for at least 2 years on a regular basis were enrolled after informed consent.
Patients will be followed for amlodipine side effects. Patients with hepatic impairment, hepatitis B and C, HIV, chelation therapy changes during the last 6 months, heart failure (EF less than 30%), AV block, any inflammation and renal failure will be excluded.
Intervention groups
In the intervention group, patients will receive amlodipine at a dose of 5 and 2.5 mg with chelator and in the control group will receive chelator only for one year. After one week of treatment with amlodipine, the dose will increase to 5 mg.
Main outcome variables
Serum ferritin level; Iron overload in cardiac T2. * MRI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190829044642N1
Registration date:2020-08-03, 1399/05/13
Registration timing:retrospective
Last update:2020-08-03, 1399/05/13
Update count:0
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
shima vakilipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5632 5379
Email address
sh.vakilipour@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effects of amlodipine addition to combination therapy of Deferiprone and Deferoxamine to reduce cardiac iron overload measurable with T2*MRI in thalassemic patients
Public title
effects of amlodipine to reduce cardiac iron overload
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. All patients had informed consent to participate in the study.
2- All thalassemia major patients referring to Amir Kabir Hospital, Arak, over 5 years old.
.3. All healthy children without any underlying hematologic or hereditary diseases except major thalassemia
Exclusion criteria:
All patients who did not have informed consent to participate and continue to participate in the study.
All patients who will undergo a chelation therapy strategy during the 12 months of study due to changes.
All patients with advanced heart failure or Ef less than 30% or AV block
All patients with MRI contraindication
All patients with liver disorders, hepatitis B and C, HIV, any inflammation and renal failure
All patients who have complications with amlodipine include edema, hypotension, palpitations, etc
Age
From 5 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 30 patients with thalassemia major who are over 5 years old and have received blood regularly for at least 2 years are included in the study. To assign patients to two groups, the block randomization method with the size of four blocks was used. Thus, using online software, the randomization sequence was generated by the block method and remained with the epidemiologist and sought to diagnose and In the first group, 15 patients received amlodipine at a dose of 2.5-5 mg with a chelator, and in the second group, 15 patients received chelator. Will receive alone for one year.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind randomized clinical trial in Amir Kabir hospital in Arak in 1398 with easy sampling. In this study, 30 patients with major thalassemia who are over 5 years old and have been receiving blood for at least 2 years on a regular basis were enrolled after informed consent. Blindness Due to the double blindness of the study means that only the relevant expert in the study is aware of the study type and study groups, while the patients and the statistical experts responsible for analyzing the data are aware. Patients in charge are not aware of the study groups and only identify patients based on groups A and B and complete the checklists accordingly
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Shahid shirudi Ave., Alamolhoda St.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.ARAKMU.REC.1397.357
Health conditions studied
1
Description of health condition studied
Major Thalasemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Cardiac iron overload
Timepoint
Will be measured at baseline and 12 months after treatment.
Method of measurement
T2*MRI
Secondary outcomes
1
Description
ferritin serum level
Timepoint
At baseline and 1, 6, 12 months after treatment
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Patients will receive amlodipine at a dose of 5 to 2.5 mg with chelator for one year. After one week of treatment with amlodipine, the dose will increase to 5 mg.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive only chelators for one year.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Shima Vakilipour
Street address
Shiroudi Ave., Alamolhoda St.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
علیرضا کمالی
Street address
Payambar-e-Azam complex, Sardasht Sq.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Shima Vakilipour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 6, Nastaran 7 Alley, Fatemie Sq., Golestan Town
City
Tehran
Province
Tehran
Postal code
3759156354
Phone
+98 21 5632 5379
Email
sh.vakilipour@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shima Vakilipour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 6, Nastaran 7 Alley, Fatemie Sq., Golestan Town
City
Tehran
Province
Tehran
Postal code
3848176341
Phone
+98 21 5632 5279
Email
sh.vakilipour@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shima Vakilipour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 6, Nastaran 7 Alley, Fatemie Sq., Golestan Town
City
Tehran
Province
Tehran
Postal code
3848176341
Phone
+98 21 5632 5379
Email
sh.vakilipour@arakmu.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