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Effect of Metoprolol on Thalassemia Cardiomyopathy

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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

Tracking Information
First Submitted Date  ICMJE May 18, 2013
First Posted Date  ICMJE May 27, 2013
Last Update Posted Date May 27, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2013)
  • ejection fraction [ Time Frame: 6 months ]
    LV contractility
  • 6 minutes walk test [ Time Frame: 6 months ]
    functional capacity
  • endsystolic volume [ Time Frame: 6 months ]
    functional capacity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2013)
patient compliance [ Time Frame: 6 months ]
drug complication,
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Metoprolol on Thalassemia Cardiomyopathy
Official Title  ICMJE The Effect of Metoprolol Succinate on the Cardiac Function of Patients With Thalassemia Cardiomyopathy a Double Blind Randomized Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE B Thalassemia
Intervention  ICMJE
  • Drug: metoprolol
    using B blocker in patient group
  • Drug: placebo
    placebo to control group
Study Arms  ICMJE
  • Active Comparator: metoprolol
    patient or intervention group
    Intervention: Drug: metoprolol
  • Active Comparator: placebo group
    control group
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2013)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01863173
Other Study ID Numbers  ICMJE 91-3502
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Javad Kojuri, Shiraz University of Medical Sciences
Study Sponsor  ICMJE Shiraz University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shiraz University of Medical Sciences
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP