Effect of Metoprolol on Thalassemia Cardiomyopathy

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

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

Study Overview

• Status: Completed
• Conditions: B Thalassemia
• Intervention / Treatment: Drug: metoprolol; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Shiraz University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: metoprolol; patient or intervention group	Drug: metoprolol; using B blocker in patient group
Active Comparator: placebo group; control group	Drug: placebo; placebo to control group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 18, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimate): May 27, 2013

Study Record Updates

• Last Update Posted (Estimate): May 27, 2013
• Last Update Submitted That Met QC Criteria: May 22, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: echocardiography; six minute walk test; metoprolol succinate; Thalassemia cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Cardiomyopathies; Thalassemia; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Metoprolol
• Other Study ID Numbers: 91-3502