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 | https://doi.org/10.1186/ISRCTN63999319 |
| Secondary identifying numbers | 001 Version 1 |
- Submission date
- 20/02/2012
- Registration date
- 28/03/2013
- Last edited
- 17/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English 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?
April 2012 to 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
Contact information
Scientific
P.O. Box 23543
Kampala
256
Uganda
| ynabunnya@yahoo.com |
Study information
| Study design | Randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | PREF |
| 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. |
| Ethics approval(s) | Makerere University College of Health Sciences School of Medicine, 23/12/2011, REC ref: 2011-252 |
| Condition | Endomyocardial fibrosis |
| Intervention | 1. Oral prednisolone 1mg/kg 2. Placebo 1mg/kg Given once a day in the morning for two months then tapered for one month. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Prednisolone |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/03/2012 |
| Overall study end date | 01/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Sex | Both |
| Target number of participants | 70 |
| Participant 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 |
| Participant exclusion criteria | 1. Critically ill patients with unstable vital parameters 2. Use of corticosteroids within the previous month for other indications 3. Pregnancy |
| Recruitment start date | 01/03/2012 |
| Recruitment end date | 01/08/2012 |
Locations
Countries of recruitment
- Uganda
Study participating centre
256
Uganda
Sponsor information
University/education
P.O.Box 7072
Kampala
256
Uganda
| Website | http://chs.mak.ac.ug/ |
|---|---|
"ROR" |
https://ror.org/03dmz0111 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/12/2015 | Yes | No |
