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effects of amlodipine to reduce cardiac iron overload

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190829044642N1
Enrollment
30
Registered
2020-08-03
Start date
2019-09-23
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Thalasemia. Beta thalassemia

Interventions

Intervention 1: 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. I

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Cardiac iron overload. Timepoint: Will be measured at baseline and 12 months after treatment. Method of measurement: T2*MRI.

Secondary

MeasureTime frame
Ferritin serum level. Timepoint: At baseline and 1, 6, 12 months after treatment. Method of measurement: ELISA.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShima Vakilipour

Arak University of Medical Sciences

sh.vakilipour@arakmu.ac.ir+98 21 5632 5379

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026