Javad Kojury1, Abdolali Zolghadrasli2, Mehran Karimi3, Mohammad Ali Babaee Beighi1, Soha Namazi4. 1. Department of Cardiology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Fars, Islamic Republic of Iran; Shiraz Cardiovascular Research Center, Shiraz, Fars, Islamic Republic of Iran. 2. Department of Cardiology , School of Medicine, Shiraz University of Medical Sciences , Shiraz, Fars , Islamic Republic of Iran. 3. Hematology Research Centre , Shiraz University of Medical Sciences , Shiraz, Fars , Islamic Republic of Iran. 4. Department of Pharmacology , Shiraz University of Medical Sciences , Shiraz, Fars , Islamic Republic of Iran.
Abstract
BACKGROUND: Heart failure is the most common cause of mortality in β-thalassaemia major. However, the management of this disease, apart from chelation therapy, is largely empirical. Therefore, we decided to evaluate the effect of metoprolol succinate on patients with thalassaemia cardiomyopathy (TCM). MATERIALS AND METHODS: In this clinical trial, 45 patients with TCM were randomised to receive either metoprolol (n=26) or placebo (n=19). Echocardiography and a 6 min walk test were performed at baseline and repeated after 6 months and the values compared. RESULTS: In the metoprolol group, left ventricular ejection fraction (LVEF) rose from 38.65% to 42.84% (p<0.001), while it decreased in the placebo group from 37.89% to 35.84% (p=0.01); the difference between the two groups was significant (p<0.001). Left ventricular (LV) mass in the metoprolol group decreased from 154.31 to 144.26 g (p=0.02), while in the placebo group it increased from 174.32 to 200.15 g (p=0.68); the difference between the two groups was significant (p<0.001). End systolic volume (ESV) decreased in the metoprolol group from 42.19 to 36.73 cm(3) (p<0.001) but increased from 47.37 to 57.42 cm(3) in the placebo group (p=0.144); the difference between the groups was significant (p<0.001). No differences in exercise capacity or pulmonary capillary wedge pressure were seen between the two groups (p=0.268 and p=0.535, respectively). CONCLUSIONS:Metoprolol succinate as a β-blocker may have the potential to significantly improve systolic function in patients with TCM and reverse LV remodelling to the same extent as in other types of cardiomyopathy. TRIAL REGISTRATION NUMBER: NCT01863173.
RCT Entities:
BACKGROUND:Heart failure is the most common cause of mortality in β-thalassaemia major. However, the management of this disease, apart from chelation therapy, is largely empirical. Therefore, we decided to evaluate the effect of metoprolol succinate on patients with thalassaemia cardiomyopathy (TCM). MATERIALS AND METHODS: In this clinical trial, 45 patients with TCM were randomised to receive either metoprolol (n=26) or placebo (n=19). Echocardiography and a 6 min walk test were performed at baseline and repeated after 6 months and the values compared. RESULTS: In the metoprolol group, left ventricular ejection fraction (LVEF) rose from 38.65% to 42.84% (p<0.001), while it decreased in the placebo group from 37.89% to 35.84% (p=0.01); the difference between the two groups was significant (p<0.001). Left ventricular (LV) mass in the metoprolol group decreased from 154.31 to 144.26 g (p=0.02), while in the placebo group it increased from 174.32 to 200.15 g (p=0.68); the difference between the two groups was significant (p<0.001). End systolic volume (ESV) decreased in the metoprolol group from 42.19 to 36.73 cm(3) (p<0.001) but increased from 47.37 to 57.42 cm(3) in the placebo group (p=0.144); the difference between the groups was significant (p<0.001). No differences in exercise capacity or pulmonary capillary wedge pressure were seen between the two groups (p=0.268 and p=0.535, respectively). CONCLUSIONS:Metoprolol succinate as a β-blocker may have the potential to significantly improve systolic function in patients with TCM and reverse LV remodelling to the same extent as in other types of cardiomyopathy. TRIAL REGISTRATION NUMBER: NCT01863173.
Authors: Mariell Jessup; William T Abraham; Donald E Casey; Arthur M Feldman; Gary S Francis; Theodore G Ganiats; Marvin A Konstam; Donna M Mancini; Peter S Rahko; Marc A Silver; Lynne Warner Stevenson; Clyde W Yancy Journal: Circulation Date: 2009-03-26 Impact factor: 29.690
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