Peripartum Cardiomyopathy in Nigeria Registry

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aminu Kano Teaching Hospital
• Collaborator: Nigerian Cardiac Society
• Treatments: Selenious Acid; Selenium; Sodium Selenite

Criteria

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