Clinical trial NCT01863173: Effect of Metoprolol on Thalassemia Cardiomyopathy
Official title: The Effect of Metoprolol Succinate on the Cardiac Function of Patients With Thalassemia Cardiomyopathy a Double Blind Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: B Thalassemia
Keywords: Thalassemia cardiomyopathy
metoprolol succinate
echocardiography
six minute walk test
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 45
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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

Primary outcomes:
measure: ejection fraction
timeFrame: 6 months
measure: 6 minutes walk test
timeFrame: 6 months
measure: endsystolic volume
timeFrame: 6 months
Secondary outcomes:
measure: patient compliance
timeFrame: 6 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
References:
citation: 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.
citation: 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.
citation: Kojury J, Zolghadrasli A, Karimi M, Babaee Beighi MA, Namazi S. The effect of metoprolol succinate on the cardiac function of patients with thalassaemia cardiomyopathy: a double-blind randomised study. Heart Asia. 2014 Apr 17;6(1):54-8. doi: 10.1136/heartasia-2013-010460. eCollection 2014.