EFFECT OF L-TYPE CALCIUM CHANNEL BLOCKER (AMLODIPINE) ON MYOCARDIAL IRON DEPOSITION IN PATIENTS WITH THALASSEMIA MAJOR: A RANDOMIZED CONTROL TRIAL.
(Abstract release date: 05/19/16)
EHA Library. Alvi N. 06/09/16; 135036; PB2136
Dr. Najveen Alvi
Contributions
Contributions
Abstract
Abstract: PB2136
Type: Publication Only
Background
Sideroblastic cardiomyopathy is a feared complication in Thalassemia Major (TM). Recent evidence suggests a role for L-type-Ca2+-channels (LTCC), in addition to standard chelation therapy, in mediating myocardial iron-uptake.
Aims
Our primary objective was to determine the efficacy of Amlodipine in reducing myocardial iron-load when compared to controls. Changes in echocardiographic derived LV function, liver T2* and iron-content were also sought.
Methods
Participants managed for over a year with a transfusion need of ≥ 180 ml/kg/year, having received ≥ 10 blood transfusions in life-time and with serum ferritin ≥ 1000 ng/dL were invited. All patients with known hypersensitivity to amlodipine, history of developing tetany with calcium channel blockers or systolic blood pressures ≤ 2 SD for age at baseline and pre-existing cardiac conditions were excluded. Twenty patients in a 1:1 allocation ratio were randomized into the intervention and control arms. Conventional echocardiographic measures, global longitudinal strain (GLS), T2* CMR and liver T2* were obtained at baseline, 6 and 12 months. Continuous and categorical variables were reported as mean (SD and CI)/median (IQR) and frequency/percent respectively. Mann-Whitney U test and Fisher exact test were used. Change in outcomes with respect to time and treatment were tested using repeated measure ANOVA. P-value of <0.05 was considered significant.
Results
10 participants in intervention arm (median age 18 IQR 15.8-19.3 years) and 9 controls (median age 16 IQR 13-18 years) were analyzed. The two groups were statistically similar at baseline. Adjusting for age, years on transfusion and chelation compliance, a statistically non-significant trend of improved cardiac T2* was seen from baseline (15.8ms, CI 6.9-24.6) to 6 months (T2*= 17.3ms, CI 8.8-25.9) in the intervention arm (p=0.77) when compared with controls. This change was sustained at 12 months (figure 1). MIC, conventional echocardiographic parameters and GLS, liver T2* and LIC did not change significantly throughout the study between the two arms.
Conclusion
Calcium channel blockers such as amlodipine show promise but larger clinical trials are needed to establish their role.
Session topic: E-poster
Keyword(s): Chelation, Thalassemia
Type: Publication Only
Background
Sideroblastic cardiomyopathy is a feared complication in Thalassemia Major (TM). Recent evidence suggests a role for L-type-Ca2+-channels (LTCC), in addition to standard chelation therapy, in mediating myocardial iron-uptake.
Aims
Our primary objective was to determine the efficacy of Amlodipine in reducing myocardial iron-load when compared to controls. Changes in echocardiographic derived LV function, liver T2* and iron-content were also sought.
Methods
Participants managed for over a year with a transfusion need of ≥ 180 ml/kg/year, having received ≥ 10 blood transfusions in life-time and with serum ferritin ≥ 1000 ng/dL were invited. All patients with known hypersensitivity to amlodipine, history of developing tetany with calcium channel blockers or systolic blood pressures ≤ 2 SD for age at baseline and pre-existing cardiac conditions were excluded. Twenty patients in a 1:1 allocation ratio were randomized into the intervention and control arms. Conventional echocardiographic measures, global longitudinal strain (GLS), T2* CMR and liver T2* were obtained at baseline, 6 and 12 months. Continuous and categorical variables were reported as mean (SD and CI)/median (IQR) and frequency/percent respectively. Mann-Whitney U test and Fisher exact test were used. Change in outcomes with respect to time and treatment were tested using repeated measure ANOVA. P-value of <0.05 was considered significant.
Results
10 participants in intervention arm (median age 18 IQR 15.8-19.3 years) and 9 controls (median age 16 IQR 13-18 years) were analyzed. The two groups were statistically similar at baseline. Adjusting for age, years on transfusion and chelation compliance, a statistically non-significant trend of improved cardiac T2* was seen from baseline (15.8ms, CI 6.9-24.6) to 6 months (T2*= 17.3ms, CI 8.8-25.9) in the intervention arm (p=0.77) when compared with controls. This change was sustained at 12 months (figure 1). MIC, conventional echocardiographic parameters and GLS, liver T2* and LIC did not change significantly throughout the study between the two arms.
Conclusion
Calcium channel blockers such as amlodipine show promise but larger clinical trials are needed to establish their role.
Session topic: E-poster
Keyword(s): Chelation, Thalassemia
Abstract: PB2136
Type: Publication Only
Background
Sideroblastic cardiomyopathy is a feared complication in Thalassemia Major (TM). Recent evidence suggests a role for L-type-Ca2+-channels (LTCC), in addition to standard chelation therapy, in mediating myocardial iron-uptake.
Aims
Our primary objective was to determine the efficacy of Amlodipine in reducing myocardial iron-load when compared to controls. Changes in echocardiographic derived LV function, liver T2* and iron-content were also sought.
Methods
Participants managed for over a year with a transfusion need of ≥ 180 ml/kg/year, having received ≥ 10 blood transfusions in life-time and with serum ferritin ≥ 1000 ng/dL were invited. All patients with known hypersensitivity to amlodipine, history of developing tetany with calcium channel blockers or systolic blood pressures ≤ 2 SD for age at baseline and pre-existing cardiac conditions were excluded. Twenty patients in a 1:1 allocation ratio were randomized into the intervention and control arms. Conventional echocardiographic measures, global longitudinal strain (GLS), T2* CMR and liver T2* were obtained at baseline, 6 and 12 months. Continuous and categorical variables were reported as mean (SD and CI)/median (IQR) and frequency/percent respectively. Mann-Whitney U test and Fisher exact test were used. Change in outcomes with respect to time and treatment were tested using repeated measure ANOVA. P-value of <0.05 was considered significant.
Results
10 participants in intervention arm (median age 18 IQR 15.8-19.3 years) and 9 controls (median age 16 IQR 13-18 years) were analyzed. The two groups were statistically similar at baseline. Adjusting for age, years on transfusion and chelation compliance, a statistically non-significant trend of improved cardiac T2* was seen from baseline (15.8ms, CI 6.9-24.6) to 6 months (T2*= 17.3ms, CI 8.8-25.9) in the intervention arm (p=0.77) when compared with controls. This change was sustained at 12 months (figure 1). MIC, conventional echocardiographic parameters and GLS, liver T2* and LIC did not change significantly throughout the study between the two arms.
Conclusion
Calcium channel blockers such as amlodipine show promise but larger clinical trials are needed to establish their role.
Session topic: E-poster
Keyword(s): Chelation, Thalassemia
Type: Publication Only
Background
Sideroblastic cardiomyopathy is a feared complication in Thalassemia Major (TM). Recent evidence suggests a role for L-type-Ca2+-channels (LTCC), in addition to standard chelation therapy, in mediating myocardial iron-uptake.
Aims
Our primary objective was to determine the efficacy of Amlodipine in reducing myocardial iron-load when compared to controls. Changes in echocardiographic derived LV function, liver T2* and iron-content were also sought.
Methods
Participants managed for over a year with a transfusion need of ≥ 180 ml/kg/year, having received ≥ 10 blood transfusions in life-time and with serum ferritin ≥ 1000 ng/dL were invited. All patients with known hypersensitivity to amlodipine, history of developing tetany with calcium channel blockers or systolic blood pressures ≤ 2 SD for age at baseline and pre-existing cardiac conditions were excluded. Twenty patients in a 1:1 allocation ratio were randomized into the intervention and control arms. Conventional echocardiographic measures, global longitudinal strain (GLS), T2* CMR and liver T2* were obtained at baseline, 6 and 12 months. Continuous and categorical variables were reported as mean (SD and CI)/median (IQR) and frequency/percent respectively. Mann-Whitney U test and Fisher exact test were used. Change in outcomes with respect to time and treatment were tested using repeated measure ANOVA. P-value of <0.05 was considered significant.
Results
10 participants in intervention arm (median age 18 IQR 15.8-19.3 years) and 9 controls (median age 16 IQR 13-18 years) were analyzed. The two groups were statistically similar at baseline. Adjusting for age, years on transfusion and chelation compliance, a statistically non-significant trend of improved cardiac T2* was seen from baseline (15.8ms, CI 6.9-24.6) to 6 months (T2*= 17.3ms, CI 8.8-25.9) in the intervention arm (p=0.77) when compared with controls. This change was sustained at 12 months (figure 1). MIC, conventional echocardiographic parameters and GLS, liver T2* and LIC did not change significantly throughout the study between the two arms.
Conclusion
Calcium channel blockers such as amlodipine show promise but larger clinical trials are needed to establish their role.
Session topic: E-poster
Keyword(s): Chelation, Thalassemia
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