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Effect of Metoprolol on Thalassemia Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01863173
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Javad Kojuri, Shiraz University of Medical Sciences

Study Description
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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

Condition or disease Intervention/treatment Phase
B Thalassemia Drug: metoprolol Drug: placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Metoprolol Succinate on the Cardiac Function of Patients With Thalassemia Cardiomyopathy a Double Blind Randomized Study
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. ejection fraction [ Time Frame: 6 months ]
    LV contractility

  2. 6 minutes walk test [ Time Frame: 6 months ]
    functional capacity

  3. endsystolic volume [ Time Frame: 6 months ]
    functional capacity


Secondary Outcome Measures :
  1. patient compliance [ Time Frame: 6 months ]
    drug complication,


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863173


Locations
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Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Javad Kojuri, professor, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01863173    
Other Study ID Numbers: 91-3502
First Posted: May 27, 2013    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013
Keywords provided by Javad Kojuri, Shiraz University of Medical Sciences:
Thalassemia cardiomyopathy
metoprolol succinate
echocardiography
six minute walk test
Additional relevant MeSH terms:
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Cardiomyopathies
Thalassemia
Heart Diseases
Cardiovascular Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Metoprolol
Anti-Arrhythmia Agents
 Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action