Effect of Metoprolol on Thalassemia Cardiomyopathy

Study Overview
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Brief Summary
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effect of B blocker was first evaluated in patient with cardiomyopathy not induced by ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on Thalassemia cardiomyopathy was evaluated in this study

Detailed Description
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In this clinical trial, 45 patients with thalassemia cardiomyopathy were randomized to receive either metoprolol (n = 26) or placebo (n = 19). Echocardiography and 6 minute walk test was performed at baseline and repeated after 6 months and the values were compared.

Official Title
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The Effect of Metoprolol Succinate on the Cardiac Function of Patients With Thalassemia Cardiomyopathy a Double Blind Randomized Study

Conditions
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B Thalassemia

Intervention / Treatment
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* Drug: metoprolol
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documented LVEF < 50% by echocardiography B thalassemia No decompensated heart failure for at least 4 weeks (hospitalization for CHF, worsening lower extremity edema, worsening dyspnea on exertion, , and orthopnea) have no evidence of acute myocarditis and hemoglobin level above 7 gr⁄dL. Exclusion Criteria: pulse rate below 60/min systolic blood pressure less than 90 mmHg evidence of peripheral vascular disease major depression, history of asthma, PR interval more than 240 msec, second or third degree AV block major medical diseases including diabetes mellitus requiring insulin injection, hypothyroidism, hypoparathyroidism, chronic renal failure (glomerular filtration rate below 30 ml/min), hepatic cirrhosis, hepatitis-B and hepatitis-C, positive tests for human immunodeficiency virus, and other hemoglobinopathies

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metoprolol<br>patient or intervention group | Drug: metoprolol<br>* using B blocker in patient group<br>|
| Active Comparator: placebo group<br>control group | Drug: placebo<br>* placebo to control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ejection fraction | LV contractility | 6 months | 
| 6 minutes walk test | functional capacity | 6 months | 
| endsystolic volume | functional capacity | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient compliance | drug complication, | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thalassemia cardiomyopathy, metoprolol succinate, echocardiography, six minute walk test