Effect of Metoprolol on Thalassemia Cardiomyopathy

B Thalassemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863173
• Other study ID #: 91-3502
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 18, 2013
• Last updated: May 22, 2013
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: iran:NIH
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 25 Years

Eligibility

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

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

Related Conditions & MeSH terms

• B Thalassemia
• Cardiomyopathies
• Thalassemia

Intervention

Drug:
• metoprolol
using B blocker in patient group
• placebo
placebo to control group

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ejection fraction	LV contractility	6 months	Yes
Primary	6 minutes walk test	functional capacity	6 months	Yes
Primary	endsystolic volume	functional capacity	6 months	Yes
Secondary	patient compliance	drug complication,	6 months	Yes