Effect of Metoprolol on Thalassemia Cardiomyopathy

Shiraz University of Medical Sciences

Status and phase

Completed

Phase 3

Phase 2

Conditions

B Thalassemia

Treatments

Drug: placebo

Drug: metoprolol

Study type

Interventional

Funder types

Other

Identifiers

NCT01863173

91-3502

Details and patient eligibility

About

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

Full description

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.

Enrollment

45 patients

Sex

All

Ages

13 to 25 years old

Volunteers

No Healthy Volunteers

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