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The efficacy and safety of prednisolone in the prevention of re-accumulation of ascites among endomyocardial fibrosis (EMF) patients at Mulago hospital
ISRCTN ISRCTN63999319
DOI 10.1186/ISRCTN63999319
ClinicalTrials.gov identifier
EudraCT number
Public title The efficacy and safety of prednisolone in the prevention of re-accumulation of ascites among endomyocardial fibrosis (EMF) patients at Mulago hospital
Scientific title The efficacy and safety of prednisolone in the prevention of re-accumulation of ascites among endomyocardial fibrosis (EMF) patients at Mulago hospital: A randomised clinical trial
Acronym PREF
Serial number at source 001 Version 1
Study hypothesis Giving oral prednisolone at 1mg/kg per day to EMF patients with grade 2 ascites will prevent 35% of these patients re-accumulating to grade 3 ascites or more.

Null hypothesis: Giving oral prednisolone at 1mg/kg per day to EMF patients with grade 2 ascites will not prevent 35% of these patients re-accumulating to grade 3 ascites or more.
Lay summary Background and study aims
Endomyocardial fibrosis is a restrictive cardiomyopathy (heart muscle disease) of unknown origin and is thought to be the most common type of restrictive cardiomyopathy worldwide. Ongoing inflammation and fibrosis in the heart and other parts of the body like the peritoneum may explain the exudative ascites (accumulation of fluid) found in these patients. Ascites is the commonest presentation of these patients in Uganda and is a source of acute discomfort and pain. Medical treatment for this ascites is disappointing. We would therefore like to study if predinisolone, an anti-inflammatory agent, can prevent re-accumulation of ascites if a patient is tapped from grade 3 or more to grade 2 in two months.
The aim of this study is to determine the efficacy and safety of prednisolone when used in preventing re-accumulation of ascites among EMF patients.
This will specifically be done by determining the efficacy of prednisolone in preventing re-accumulation of ascites from grade 2 to grade 3 or more among EMF patients attending Mulago hospital cardiology service. Secondly, describe the adverse effects of prednisolone when used in preventing re-accumulation of ascites among EMF patients attending Mulago cardiology service.

Who can participate?
Patients with a diagnosis of EMF and have ascites, both sexes, 13years and older who have consented to participate in the trial. Patients will be excluded if they are found to be critically ill with unstable vital parameters, are using steroids within the previous month for any other indication or if they are found to be pregnant.

What does the study involve?
Participants are randomly allocated to receive either Oral prednisolone 1mg/kg or placebo (dummy), given once a day in the morning for two months then tapered for one month.

What are the possible benefits and risks of participating?
Subjects will receive free trial medication and check-ups throughout the duration that they will be in the study. If the study finds that the drugs being tested are effective in reducing ascites due to EMF, the information generated will help to improve the treatment, and hopefully, the quality of life of many people suffering from Endomyocardial fibrosis with debilitating ascites. They will have contributed significantly for the benefit of many more people who might be having Endomyocardial fibrosis in this country and many other parts of the World.
All procedures of this study involve no more than minimal risk to you as a participant. Paracentesis (form of body fluid sampling procedure) will be done by an experienced doctor. You might experience pain on the site of the injection or site of blood draw for a short period. There is also a small chance that steroids could increase the risk of infection. Very rarely prednisone can cause high blood pressure and diabetes. You will be monitored for these side effects and, the treatment will be stopped if necessary. Fortunately these side effects do disappear when prednisolone is stopped. Pregnant women will however be excluded to protect the foetus and contraception will be advised among those who will be included in the study. Overall the benefits will outweigh the risks.

Where is the study run from?
Mulago hospital cardiology service (Mulago hospital ward 4C cardiology, Cardiology clinic and Uganda heart institute Mulago.

When is the study starting and how long is it expected to run for?
Study started in April 2012 and ran till August 2012

Who is funding the study?
Makerere University College of Health Sciences, Uganda - MEPI-CVD Linked project

Who is the main contact?
Dr.Nabunnya Yvonne Brenda Musana
ynabunnya@yahoo.com
Ethics approval Makerere University College of Health Sciences School of Medicine, 23rd December 2011, REC ref: 2011-252
Study design Randomised placebo controlled trial
Countries of recruitment Uganda
Disease/condition/study domain Endomyocardial fibrosis
Participants - 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
Participants - exclusion criteria 1. Critically ill patients with unstable vital parameters
2. Use of corticosteroids within the previous month for other indications
3. Pregnancy
Anticipated start date 01/03/2012
Anticipated end date 01/08/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 70
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.
Primary outcome measure(s) 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 outcome measure(s) 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.
Sources of funding Makerere University College of Health Sciences (Uganda) - MEPI-CVD Linked project
Trial website
Publications
Contact name Dr  Yvonne  Nabunnya
  Address P.O.BOX 23543
  City/town Kampala
  Zip/Postcode 256
  Country Uganda
  Email ynabunnya@yahoo.com
Sponsor Makerere University College of Health Sciences (Uganda)
  Address P.O.Box 7072
  City/town Kampala
  Zip/Postcode 256
  Country Uganda
  Sponsor website: http://chs.mak.ac.ug/
Date applied 20/02/2012
Last edited 28/03/2013
Date ISRCTN assigned 28/03/2013
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