Effect of Metoprolol on Thalassemia Cardiomyopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Javad Kojuri, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01863173
First received: May 18, 2013
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
B Thalassemia
Drug: metoprolol
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    LV contractility

  • 6 minutes walk test [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    functional capacity

  • endsystolic volume [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    functional capacity


Secondary Outcome Measures:
  • patient compliance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    drug complication,


Enrollment: 45
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 25 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01863173

Locations
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

Publications:
Responsible Party: Javad Kojuri, professor, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01863173     History of Changes
Other Study ID Numbers: 91-3502
Study First Received: May 18, 2013
Last Updated: May 22, 2013
Health Authority: iran:NIH

Keywords provided by Shiraz University of Medical Sciences:
Thalassemia cardiomyopathy
metoprolol succinate
echocardiography
six minute walk test

Additional relevant MeSH terms:
Beta-Thalassemia
Thalassemia
Cardiomyopathies
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Heart Diseases
Cardiovascular Diseases
Metoprolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on April 17, 2014