Abstract
BackgroundEndomyocardial fibrosis (EMF), the commonest restrictive cardiomyopathy worldwide, is characterized by inflammation and fibrosis of the endocardium. Inflammation in other parts of the body such as the peritoneum has been described and may explain the accumulation of ascites, a painful and disabling feature of this disease. We determined the efficacy and safety of prednisolone to prevent re-accumulation of ascites among EMF patients attending Mulago hospital cardiology service.MethodsThis was a pilot randomised placebo controlled trial with a 1:1 parallel design. Over a period of 10 months, participants were recruited and randomized to receive 1 mg/kg per day of prednisolone or placebo and were followed for a maximum of 8 weeks. The primary outcome was re-accumulation of ascites from baseline (grade 2) to grade 3. Safety was assessed by self-reported side effects, physical exam, and laboratory assessment.ResultsSixteen study participants were randomised to prednisolone, while nineteen were randomised to placebo. Six were lost to follow up (1-prednisolone arm, 5-placebo). Baseline characteristics were similar between groups. Prednisolone was safely administered in this setting. There was no statistically significant difference in the overall risk of developing grade 3 ascites over 8 weeks. RR (95 % confidence interval) 0.70 (0.43–1.11), P value 0.12. The rate of the primary outcome per 1000 person days of follow-up was also similar in both arms P value 0.63.ConclusionShort term prednisolone use was generally safe and did not prevent reaccumulation of ascites in this study population.Trial registration number: ISRCTN63999319, 28/03/2013
Highlights
Endomyocardial fibrosis (EMF), the commonest restrictive cardiomyopathy worldwide, is characterized by inflammation and fibrosis of the endocardium
The use of corticosteroids in the management of EMF, not backed by randomised clinical trials, is informed by the pathological finding of global inflammation and fibrosis which is not limited to the heart
Significant baseline laboratory characteristics include the following: peripheral eosinophilia (>10 % of total leukocytes) was observed in only 10 % of patients (Fig. 2), majority (97 %) had a transudative ascites, with 80 % having a lymphocytic predominance of cells on ascitic fluid analysis
Summary
Endomyocardial fibrosis (EMF), the commonest restrictive cardiomyopathy worldwide, is characterized by inflammation and fibrosis of the endocardium. Endomyocardial fibrosis (EMF) is the commonest restrictive cardiomyopathy worldwide It was first recognized during the 1940s and is still a cause of heart failure in Uganda [1]. Prednisolone is an intermediate acting corticosteroid drug with predominant glucocorticoid and low mineral corticoid activity, making it useful for the treatment of a wide range of inflammatory and auto-immune conditions. It is well absorbed from the gastrointestinal tract, and widely distributed throughout the body plasma protein bound on transcortin and albumin. It was chosen because it is inexpensive and readily available in Uganda. It has a moderate side effect profile and the pill burden is limited compared to other corticosteroids such as dexamethasone
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