Aim of this study is the effect of Amlodipine in reduce iron levels in patients with major Thalassemia who referred to Arak Amirkabir hospital. Inclusion criteria: Patients with major Thalassemia with regular blood transfusions; using iron chelating agents regularly; age above 7 years old.
Exclusion criteria: Patients who changed their chelating agents during the last 6 months; renal and hepatic failure; cardiac output less than 35%; systolic blood pressure less than 90 millimeter Hg; patients with HIV and hepatitis B and C. We will measure complete blood count (CBC) and liver function test (LFT) and renal function test (BUN / Cr) and ferritin level and hepatitis serology B, C, HIV and echocardiography and T2*MRI of heart and liver and ejection fraction(EF) for all patients before study. We will divide patients to two groups. We prescribe chelating agent in control group and Amlodipine addition chelator agents in intervention group. If systolic blood pressure is above 90 millimeter Hg, We will prescribe 2.5 mg Amlodipine once daily for first week. If blood pressure is normal, We prescribe 5 mg Amlodipine once daily for12 months. We will measure ferritin levels 1 and 6 and 12 months after treatment. We will check blood pressure monthly. We will measure T2*MRI of heart and liver after 6 and 12 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080720715N2
Registration date:2017-03-27, 1396/01/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-27, 1396/01/07
Registrant information
Name
Aziz Eghbali
Name of organization / entity
دانشگاه علوم پزشکی اراک
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 5314
Email address
dr.eghbali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-05-27, 1394/03/06
Expected recruitment end date
2016-08-27, 1395/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Amlodipine on reduce of iron overload in patients with major thalassemia above 7 years old
Public title
Effect of Amlodipine on reduce of iron overload in patiens with thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with major thalassemia with regular blood transfusions; using iron chelating agents regularly; age above 7 years old.
Exclusion criteria: Patients who changed their chelating agents during the last 6 months; renal and hepatic failure; cardiac output less than 35%; systolic blood pressure less than 90 millimeter Hg, patients with HIV and hepatitis B and C.
Age
From 7 years old to 54 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomize by table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences