Investigation in Pregnancy Associate Cardiomyopathy (NCT01085955) | Clinical Trial Compass
CompletedNot Applicable
Investigation in Pregnancy Associate Cardiomyopathy
United States, Canada100 participantsStarted 2009-10
Plain-language summary
Peri-partum cardiomyopathy is a heart muscle weakness that occurs during or following pregnancy. Research suggests that many initial heart injuries including viruses, pregnancy and other unknown causes, can lead to a process of inflammation of the heart muscle which can weaken the heart and cause cardiomyopathy. Why this process occurs in women during pregnancy is not well understood and if it differs from those women who develop cardiomyopathy from a virus is unknown. This study has been proposed to look at genetic information (DNA) as well as the immune system (the body's response to fight off infections and/or viruses) to find possible causes for the heart muscle damage that occurs in peripartum cardiomyopathy.
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient of 16 years of age or older
* Diagnosis of peripartum cardiomyopathy
* Presentation for enrollment no earlier than one month pre-term and no later than two months post partum.
* LVEF less than OR equal to 0.45 by echocardiogram
Additional inclusion criteria for MRI substudy:
* Must be post partum
* Participant is not breast feeding or is willing to forego breast feeding for 24 hours post gadolinium.
Exclusion Criteria:
* Previous diagnosis of cardiomyopathy, valvular disease or complex congenital heart disease
* Evidence of CAD (\>50% stenosis of major epicardial vessel or positive non-invasive stress test)
* Previous cardiac transplant
* Chemotherapy or chest radiation within 5 years of enrollment
* Evidence of ongoing bacterial septicemia (positive blood cultures)
* Medical, social, or psychiatric condition which limit the ability to comply with follow-up (Example: alcohol or drug abuse)
Additional Exclusion for MRI Substudy
* GFR \< 30mL/1.7 m2 by MDRD equation (http://www.kidney.org/professionals/kdogi/gfr\_calculator.cfm)
* Currently breast feeding or unwilling to forego for 24 hour period post gadolinium
* Implanted devices (cochlear implants, pacemakers, defibrillators, infusion pumps, nerve stimulators, etc)
* Cerebral aneurysm clips
* Swan Ganz catheter or intra aortic balloon pump
* Ocular metal or metallic splinters in the eye
* Pregnant women
* Metal shrapnel or bullet
* Allergy to Gadolinium
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate systemic immune activation as the etiology of PPCM