Skip to main content
OpenTrials
Completed

NCT Number: NCT01863173

Effect of Metoprolol on Thalassemia Cardiomyopathy

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metoprolol

Drug

using B blocker in patient group

Placebo

Drug

placebo to control group

Primary outcomes

  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 outcomes

  1. patient compliance

    Time frame: 6 months

    drug complication,

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 27, 2013
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.