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Investigation of the effect of oral amlodipine on cardiac and liver iron load and echocardiographic indices in patients with beta-thalassemia major

Protocol summary

Study aim
The primary aim of this study is to evaluate the effect of oral amlodipine on cardiac and hepatic iron load in patients with major thalassemia.
Design
This is a phase 3, randomized, parallel, triple-blind, multicenter clinical trial with a placebo control. Fifty patients will be randomly assigned 1:1 using permuted blocks via SealedEnvelope.com, and study medication will be packaged with coded randomization.
Settings and conduct
Eligible patients with major thalassemia and cardiac iron overload will be enrolled and randomly assigned to amlodipine or placebo using permuted blocks. The investigator, participant, and Data Safety Monitoring Committee will remain blinded. Cardiac iron load will be measured by MRI-T2* at baseline and after 12 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with major thalassemia, aged ≥8 years, with significant cardiac iron overload Exclusion criteria: known allergy to amlodipine, refusal to take the study medication, or inability to follow study procedures
Intervention groups
Intervention group: participants will receive 5 mg oral amlodipine daily for 12 months, continuing their usual iron-chelation regimen Control group: participants will receive a placebo identical in appearance for 12 months, with their iron-chelation regimen unchanged
Main outcome variables
Cardiac iron deposition, hepatic iron deposition, left ventricular cardiac output index, left ventricular end-diastolic and end-systolic volumes, early (E) and late (A) diastolic filling velocities and their ratio (E/A), mitral annular velocity (e’), and serum ferritin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250421065432N1
Registration date: 2026-02-17, 1404/11/28
Registration timing: prospective

Last update: 2026-02-17, 1404/11/28
Update count: 0
Registration date
2026-02-17, 1404/11/28
Registrant information
Name
Alireza Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3362 2885
Email address
dralirezazamani72@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-02-20, 1404/12/01
Expected recruitment end date
2027-02-20, 1405/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of oral amlodipine on cardiac and liver iron load and echocardiographic indices in patients with beta-thalassemia major
Public title
Oral Amlodipine and Cardiac Iron load in Beta-Thalassemia Major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with β-thalassemia major ≥ 8 years old Increased myocardial iron overload
Exclusion criteria:
Known hypersensitivity or allergy to amlodipine Unwillingness to take the study medication Unwillingness to participate in the study Inability or unwillingness to follow study instructions (poor compliance)
Age
From 8 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be a randomized, parallel-group, double-blind, placebo-controlled, multicenter clinical trial. Based on the determined sample size, 50 patients will be allocated in a 1:1 ratio to either the intervention or control group. Randomization will be performed using permuted block randomization with a block size of 4 to ensure balanced allocation between the groups. Each patient will be considered an independent unit. The randomization sequence will be generated using the online statistical service sealedenvelope.com. To ensure allocation concealment, the sequence will be placed in sequentially numbered, sealed, opaque envelopes. The enrolling investigators will be blinded to group assignment, and an envelope will only be opened after a patient is formally enrolled.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The active drug and placebo will be manufactured as tablets identical in appearance, size, color, odor, and packaging by a pharmacotherapy specialist at Mofid Children's Hospital. Medication packages will be labeled only with a unique patient identification code and stored in the central research pharmacy. After eligibility is confirmed and informed consent is obtained, each enrolled patient will be sequentially assigned an identification code. The pharmacy will then dispense the corresponding monthly medication package. All paraclinical assessments will be performed by trained technicians and physicians who are blinded to the patient's treatment assignment. Following the completion of the 12-month treatment period and data collection, a blinded statistician will conduct the preliminary analysis using coded groups (A and B). After review and approval by the monitoring committee, the sealed envelopes containing the allocation codes will be opened by an independent, blinded party (the research manager) to reveal the actual group assignments for the final analysis. Finally, participants and research staff will be asked to guess the assigned treatment group to assess the success of blinding.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, School of Medicine, Shahid Beheshti University of Medical Sciences
Street address
Ethics Committee, School of Medicine, Shahid Beheshti University of Medical Sciences, Shahid Chamran Highway, Yemen St., Shahid Arabi St., Next to Ayatollah Taleghani Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
193954719
Approval date
2024-10-08, 1403/07/17
Ethics committee reference number
IR.SBMU.MSP.REC.1403.406

Health conditions studied

1

Description of health condition studied
Beta-thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia major

2

Description of health condition studied
Myocardial siderosis
ICD-10 code
I51.9
ICD-10 code description
Heart disease, unspecified

3

Description of health condition studied
Hepatic iron load
ICD-10 code
K76.89
ICD-10 code description
Other specified diseases of liver

4

Description of health condition studied
Ferritin serum level
ICD-10 code
R79.89
ICD-10 code description
Other specified abnormal findings of blood chemistry

Primary outcomes

1

Description
Cardiac iron measured by MRI-T2*
Timepoint
Myocardial iron deposition is measured at the baseline (before the intervention) and 12 months after the administration of amlodipine.
Method of measurement
cardiac MRI (T2*- MRI)

Secondary outcomes

1

Description
Left ventricular ejection fraction measured by echocardiography
Timepoint
Cardiac indices are measured at the baseline (before the intervention) and 12 months after the administration of amlodipine.
Method of measurement
echocardiography

2

Description
Hepatic iron load measured by MRI
Timepoint
Hepatic iron deposition is measured at the baseline (before the intervention) and 12 months after the administration of amlodipine.
Method of measurement
liver MRI

3

Description
Serum ferritin level
Timepoint
Serum ferritin level is measured at the baseline (before the intervention) and 12 months after the administration of amlodipine.
Method of measurement
ELISA

4

Description
Left ventricular end-diastolic volume measured by echocardiography
Timepoint
Cardiac indices are measured at the baseline (before the intervention) and 12 months after the administration of amlodipine.
Method of measurement
echocardiography

5

Description
Left ventricular end-systolic volume measured by echocardiography
Timepoint
Cardiac indices are measured at the baseline (before the intervention) and 12 months after the administration of amlodipine.
Method of measurement
echocardiography

6

Description
Early (E) to late (A) ventricular filling velocities (E/A ratio) measured by echocardiography
Timepoint
Cardiac indices are measured at the baseline (before the intervention) and 12 months after the administration of amlodipine.
Method of measurement
echocardiography

7

Description
Mitral annular velocity (e’) measured by echocardiography
Timepoint
Cardiac indices are measured at the baseline (before the intervention) and 12 months after the administration of amlodipine.
Method of measurement
echocardiography

Intervention groups

1

Description
Intervention group:Patients in the intervention group will receive one oral tablet of amlodipine daily for a period of 12 months. The dosage will be 5 mg for patients weighing ≥30 kg and 2.5 mg for patients weighing <30 kg. The tablets will be manufactured by Rooz Darou Pharmaceutical Company and administered orally. The patients’ standard iron chelation regimen will be continued without any modification.
Category
Treatment - Drugs

2

Description
Control group:Patients in the control group will receive one oral placebo tablet daily for a period of 12 months. The placebo will be identical to amlodipine in terms of appearance, color, packaging, and taste, with the only difference being the absence of the active ingredient. The tablets will be manufactured by Rooz Darou Pharmaceutical Company and administered orally. The patients’ standard iron chelation regimen will be continued without any modification.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofid Childrens Hospital
Full name of responsible person
Alireza Zamani
Street address
Mofid Children’s Hospital, Shariati Street, above Hosseiniyeh Ershad, before Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15514-15468
Phone
+98 21 2222 7021
Email
dralirezazamani72@gmail.com

2

Recruitment center
Name of recruitment center
Shohada-e-Tajrish Hospital
Full name of responsible person
Alireza Zamani
Street address
Shohada-ye Tajrish Hospital, Darband Street, Ghods Square, Tajrish, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
dralirezazamani72@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Shahid Chamran Highway, Yemen St., Shahid Arabi St., Next to Ayatollah Taleghani Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19395 4719
Phone
+98 21 8670 5503
Email
info@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samin Alavi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Hematology and Oncology Research Center, Mofid Children’s Hospital, Shariati Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15514-15468
Phone
+98 21 2222 7021
Email
saminalavi@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samin Alavi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Hematology and Oncology Research Center, Mofid Children’s Hospital, Shariati Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15514-15468
Phone
+98 21 2222 7021
Email
saminalavi@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Zamani
Position
Subspecialty Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Hematology and Oncology Research Center, Mofid Children’s Hospital, Shariati Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15514-15468
Phone
+98 21 2222 7021
Email
dralirezazamani72@gmail.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
Due to privacy, we do not plan for sharing the other data.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
The data of the subjects will be provided considering their private data.
When the data will become available and for how long
Access period start: 6 months after results publication
To whom data/document is available
The data will be provided to all readers who ask for it.
Under which criteria data/document could be used
The data will be provided through sending email to the corresponding author.
From where data/document is obtainable
The request for data could be sent to: saminalavi@hotmail.com
What processes are involved for a request to access data/document
At least six months after results publication, data will be provided to the requester by e-mail upon submission of a request and explanation of its purpose, within less than one month.
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