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Effect of Metoprolol on Thalassemia Cardiomyopathy

Primary Purpose

B Thalassemia

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
metoprolol
placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Thalassemia focused on measuring Thalassemia cardiomyopathy, metoprolol succinate, echocardiography, six minute walk test

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

metoprolol

placebo group

Arm Description

patient or intervention group

control group

Outcomes

Primary Outcome Measures

ejection fraction
LV contractility
6 minutes walk test
functional capacity
endsystolic volume
functional capacity

Secondary Outcome Measures

patient compliance
drug complication,

Full Information

First Posted
May 18, 2013
Last Updated
May 22, 2013
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01863173
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Thalassemia
Keywords
Thalassemia cardiomyopathy, metoprolol succinate, echocardiography, six minute walk test

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metoprolol
Arm Type
Active Comparator
Arm Description
patient or intervention group
Arm Title
placebo group
Arm Type
Active Comparator
Arm Description
control group
Intervention Type
Drug
Intervention Name(s)
metoprolol
Intervention Description
using B blocker in patient group
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo to control group
Primary Outcome Measure Information:
Title
ejection fraction
Description
LV contractility
Time Frame
6 months
Title
6 minutes walk test
Description
functional capacity
Time Frame
6 months
Title
endsystolic volume
Description
functional capacity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
patient compliance
Description
drug complication,
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16865210
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.
Results Reference
background
PubMed Identifier
21055653
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.
Results Reference
background
PubMed Identifier
27326168
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.
Results Reference
derived

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Effect of Metoprolol on Thalassemia Cardiomyopathy

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