Effect of Metoprolol on Thalassemia Cardiomyopathy

Phase 2

Completed

• Conditions: B Thalassemia
• Interventions: Drug: placebo; Drug: metoprolol

• Registration Number: NCT01863173
• Lead Sponsor: Shiraz University of Medical Sciences

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-05
• Study Completion: 2012-12
• Status Verified: 2013-05
• Study First Submitted: 2013-05-18
• Study First Submitted QC: 2013-05-22
• Last Update Submitted: 2013-05-22
• Study First Posted: 2013-05-27
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	control group
metoprolol	metoprolol	patient or intervention group

Primary Outcome Measures

Name	Time	Method
ejection fraction	6 months	LV contractility
endsystolic volume	6 months	functional capacity
6 minutes walk test	6 months	functional capacity

Secondary Outcome Measures

Name	Time	Method
patient compliance	6 months	drug complication,

Trial Locations

Locations (1)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of