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Effect of Metoprolol on Thalassemia Cardiomyopathy

Information source: Shiraz University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: B Thalassemia

Intervention: metoprolol (Drug); placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Shiraz University of Medical Sciences

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

ejection fraction

6 minutes walk test

endsystolic volume

Secondary outcome: patient compliance

Detailed 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.

Eligibility

Minimum age: 13 Years. Maximum age: 25 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Shiraz University of Medical Sciences, Shiraz, Fars, Iran, Islamic Republic of
Additional Information

Related publications:

Atiq M, Bana M, Ahmed US, Bano S, Yousuf M, Fadoo Z, Khurshid M. Cardiac disease in beta-thalassaemia major: Is it reversible? Singapore Med J. 2006 Aug;47(8):693-6.

Murphy CJ, Oudit GY. Iron-overload cardiomyopathy: pathophysiology, diagnosis, and treatment. J Card Fail. 2010 Nov;16(11):888-900. doi: 10.1016/j.cardfail.2010.05.009. Epub 2010 Jul 3. Review.

Starting date: January 2012
Last updated: May 22, 2013

Page last updated: August 23, 2015

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