Evaluation of the effect of amilodipine on heart function and cardiac iron deposition in β-thalassemia patients: A randomized double blind crosss-over study
Evaluation of the effect of amilodipine on heart function and cardiac iron deposition in β-thalassemia patients
Design
Randomized, double blind cross over clinical trial
Settings and conduct
The study will be conducted in Bouali Sina Educational Hospital in Sari. Patients will receive amlodipine 5 mg daily or placebo for 6 months. The order of intervention (first amlodipine then placebo or vice versa) will be determined randomly. The wash out period will be 2 weeks. Measurement of ferritin levels and MRI T2 evaluation will be performed at the start of the study, on the 6th and 12th months. C
Participants/Inclusion and exclusion criteria
Inclusion criteria : 1. beta-thalassemia patients with moderate to severe heart sediment (MRI based on a less than 15 milliseconds) 2. Age over 18 years 3. Conscious written consent
Exclusion criteria: 1. Other medicines for calcium blocker (verapamil-diltiazem-cartidilol) 2. Continuous hypotension due to heart failure severity 3. Aortic valve stenosis 4. Sinoatrial node disease 5. Heart failure
Intervention groups
Intervention group: amlodipine tablets 5 mg daily for 6 months
Control group: Amlodipine placebo daily for 6 months
Main outcome variables
Cardiac MRI T2
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090613002027N15
Registration date:2019-08-26, 1398/06/04
Registration timing:retrospective
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of amilodipine on heart function and cardiac iron deposition in β-thalassemia patients: A randomized double blind crosss-over study
Public title
ٍEffect of amilodipine on heart function and cardiac iron deposition in β-thalassemia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Beta-thalassemia patients with moderate to severe heart sediment (MRI based on a less than 15 milliseconds)
Age over 18 years
Written informed consent
Exclusion criteria:
Use of other calcium channel blockers (verapamil-diltiazem-carvedilol)
Continuous hypotension due to heart failure severity
Aortic valve stenosis
Sinoatrial node diseas
Heart failure
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization will be performed for patients based on MRI before enrollment in the study [MRI T2 of 10 to 15 milliseconds (moderate iron deposition in the heart) and MRI T2 of less than 10 milliseconds (severe iron deposition in the heart). ٌWhether the patient receives first Amlodipine then Placebo or first Placebo then Amlodipine will be determined by block randomization with 4 cases in each block. Drugs and placebo will be put in containers with the same shape. The patients and the physician will not be aware of the group they are assigned to.
Blinding (investigator's opinion)
Double blinded
Blinding description
A separate 5-digit code obtained from the computer will be assigned to each patient.The intervention, including the drug or placebo, will be placed in identical containers, and the senior researcher will insert the code on the containers. The researcher and patient will not be aware of the type of intervention received.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of mazandaran university of medical sciences
Street address
School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Khazar Square
City
sari
Province
Mazandaran
Postal code
861-48175
Approval date
2019-01-06, 1397/10/16
Ethics committee reference number
IR.MAZUMS.REC.1398.280
Health conditions studied
1
Description of health condition studied
β-thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Cardiac MRI T2
Timepoint
Baseline, month 6 and month 12
Method of measurement
Performing MRI T2
2
Description
Left Ventricular End Diastolic Diameter (LVEDD)
Timepoint
Baseline, month 6 and month 12
Method of measurement
Echoardiography
3
Description
Left Ventricular End Systolic Diameter (LVESD)
Timepoint
Baseline, month 6 and month 12
Method of measurement
Ecocardiography
Secondary outcomes
1
Description
Ferritin
Timepoint
Baseline, month 6 and month 12
Method of measurement
Kit of ferritin assay
Intervention groups
1
Description
Intervention group: amlodipine tablets 5 mg daily for 6 months
Category
Treatment - Drugs
2
Description
Control group: Amlodipine placebo daily for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
BooAli Sina Educational Hospital, Sari
Full name of responsible person
ابراهیم صالحی فر
Street address
BooAli Sina Hospital, Blvd.Pasdaran, Sari, Iran
City
sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3334 3010
Email
esalehifar@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
دکتر مجید سعیدی
Street address
Research Deputy, Mazandaran university of medical Sciences, Moallem Square, Sari, Iran
City
sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
salehifare@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar squar
City
sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
salehifare@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Khazar Square
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
salehifare@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD