Effect of Metoprolol on Thalassemia Cardiomyopathy

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01863173

Enrollment

Registered

2013-05-27

Start date

2012-01-31

Completion date

2012-12-31

Last updated

2013-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B Thalassemia

Keywords

Thalassemia cardiomyopathy, metoprolol succinate, echocardiography, six minute walk test

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.

Interventions

DRUGmetoprolol

using B blocker in patient group

DRUGplacebo

placebo to control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

13 Years to 25 Years

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

Design outcomes

Primary

Measure	Time frame	Description
ejection fraction	6 months	LV contractility
6 minutes walk test	6 months	functional capacity
endsystolic volume	6 months	functional capacity

Secondary

Measure	Time frame	Description
patient compliance	6 months	drug complication,

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026