Endomyocardial fibrosis Circulatory System Endomyocardial (tropical) fibrosis
Conditions
Interventions
1. Oral prednisolone 1mg/kg
2. Placebo 1mg/kg
Given once a day in the morning for two months then tapered for one month.
Sponsors
Makerere University College of Health Sciences (Uganda)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 13 years and older, either sex 2. Patients with a diagnosis of endomyocardial fibrosis and ascites 3. For patients already on corticosteroids a wash out period of 1month will be allowed before recruitment into the trial 4. Consent/ assent to participate in the trial
Exclusion criteria
Exclusion criteria: 1. Critically ill patients with unstable vital parameters 2. Use of corticosteroids within the previous month for other indications 3. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Variables to determine efficacy will include proportion of patients receiving prednisolone prevented from re- accumulating ascites from grade 2 to grade 3 at the end of two months of treatment. 2. Time to re-accumulation of ascites from grade 2 to grade 3 (requirement for paracentesis) 3. Cummulative increase in abdominal girth from baseline until requirement for paracentesis | — |
Secondary
| Measure | Time frame |
|---|---|
| Variables to determine the safety profile of prednisolone when given to these patients will be measured a questionnaire containing questions on particular side effects as well as physical examination and investigations will be used to determine these side effects and grade them as mild moderate and severe. | — |
Countries
Uganda
Outcome results
None listed