Improvement of MRI assessed cerebral Perfusion and oxygenation by luspatercept-induced Anemia Correction in non-transfusion dependent Thalassemia

Conditions

Non-transfusion dependent beta-thalassmia

Brief summary

Cerebral metabolic rate of oxygen (CMRO2) is measured by MRI technique by T2 relaxation under spin tagging (TRUST).

Detailed description

CBF will be measured by time-encoded CASL., Transthoracic echocardiography will be performed in order to assess the TRV. These assessments will be performed at baseline, and 27 weeks later. If transthoracic echocardiography to assess the TRV has been performed within one year before the first study visit (prior to inclusion of the patient in the study), that previously performed transthoracic echocardiography will be used as baseline transthoracic echocardiography for this study., General laboratory analysis will be performed on venous blood samples at baseline, every three weeks after start of treatment until week 27. Analysis consists of hemoglobin, leukocyte and platelet count, renal and liver assessments and NT-proBNP.

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Interventions

DRUGReblozyl 75 mg powder for solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cerebral metabolic rate of oxygen (CMRO2) is measured by MRI technique by T2 relaxation under spin tagging (TRUST).	—

Secondary

Measure	Time frame
CBF will be measured by time-encoded CASL., Transthoracic echocardiography will be performed in order to assess the TRV. These assessments will be performed at baseline, and 27 weeks later. If transthoracic echocardiography to assess the TRV has been performed within one year before the first study visit (prior to inclusion of the patient in the study), that previously performed transthoracic echocardiography will be used as baseline transthoracic echocardiography for this study., General laboratory analysis will be performed on venous blood samples at baseline, every three weeks after start of treatment until week 27. Analysis consists of hemoglobin, leukocyte and platelet count, renal and liver assessments and NT-proBNP.	—

Measure

Time frame

CBF will be measured by time-encoded CASL., Transthoracic echocardiography will be performed in order to assess the TRV. These assessments will be performed at baseline, and 27 weeks later. If transthoracic echocardiography to assess the TRV has been performed within one year before the first study visit (prior to inclusion of the patient in the study), that previously performed transthoracic echocardiography will be used as baseline transthoracic echocardiography for this study., General laboratory analysis will be performed on venous blood samples at baseline, every three weeks after start of treatment until week 27. Analysis consists of hemoglobin, leukocyte and platelet count, renal and liver assessments and NT-proBNP.

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Countries

Netherlands

Outcome results

None listed