Peripartum Cardiomyopathy in Nigeria Registry (NCT03081949) | Clinical Trial Compass
CompletedPhase 4
Peripartum Cardiomyopathy in Nigeria Registry
Nigeria100 participantsStarted 2017-06-12
Plain-language summary
Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and mortality, and Nigeria probably has the highest burden of the disease in the world. Unfortunately, much about the disease including its aetiology, epidemiology and treatment is not yet well described. This will be a prospective, national, multicenter cohort study, conducted in centres in Nigeria. It is expected that approximately 500 patients with PPCM and 500 apparently healthy pregnant women will be recruited over a 6-month period with follow-up at 3-monthly intervals for 18 months.
Who can participate
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:
* Confirmed diagnosis of PPCM
* PPCM patients with HF symptoms at the time of recruitment
* Asymptomatic pregnant women attending antenatal clinic (ANC)
* Sub-study: Open-label randomised Trial: Non-pregnant PPCM patients with all of the following: LVEF \<35% and/or LVEDDi≤33.0 mm/m2 at 6 months postpartum AND selenium deficiency
* Written informed consent
Exclusion Criteria:
* Asymptomatic PPCM patients at the time of recruitment
* PPCM patients who are not expected to survive at least 6 months from recruitment
* Pregnant women with any medical condition other than PPCM
* Subjects who are considered not likely to attend follow up reviews regularly, because of lack of patient's and close relative's phone numbers, or long distance from the study centre, etc
* Refusal or withdrawal of consent
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
Prevalence of peripartum cardiomyopathy (PPCM) in Nigeria