Who can participate?
Children, teens and adults, 8 years and older, who:
- Are being treated, or will be treated, with Aldactone
What will happen in the study?
This is an observational research study; therefore, we will not be using any new or investigational medication. During this study, we will be collecting information from you or your child’s electronic medical records, routine clinic visits and laboratory test follow-up visits.
The following procedures are part of the routine clinical care that you or your child receives. We will collect information from these procedures/visits as part of this research study.
Every 6 months:
- Review demographic information, medical history and medication
- Physical exam: including height, weight and vital signs (oral temperature, blood pressure, heart rate and the number of breaths you or your child take in 60 seconds)
- Electrocardiogram (ECG): an electrical tracing of the heartbeat or heart rhythm
- Blood sample: for routine clinical laboratory testing Every year:
- Cardiac MRI: a non-invasive test to see the function and structure of the heart
- Echocardiogram (echo): an ultrasound of the heart
If you or your child has been prescribed Aldactone (spironolactone) as part of your treatment, your doctor will also ask you to visit the nearest local laboratory on several occasions so blood samples can be collected (at 1 month, 3 months, 6 months and every 6 months thereafter you or your child begin taking Aldactone). The doctor will also ask for these tests 1 week after any dosing changes. We will collect information from your routine laboratory testing as part of this study.
You, as a participant or as a parent/guardian, will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
You or your child may not receive any direct benefit from participating in this study. When we finish the study, we hope to know more about scarring in the heart and that this may help other people with DMD later on.