Rationale and Design for the Peripartum Cardiomyopathy in Nigeria (PEACE) Registry

Abstract

Background: Nigeria probably has the highest burden of Peripartum Cardiomyopathy (PPCM) in the world. The primary objective is to describe the burden, ventricular remodelling and outcomes (rehospitalisation rate, cardio-embolic events and survival) of PPCM in Nigeria. In the sub-studies, we aim to describe the relationship between selenium deficiency, oxidative stress and PPCM, the impact of sodium selenite supplementation on cardiac function in PPCM, and the prevalence of selenium deficiency and its relationship with cardiac function in apparently healthy pregnant women.Methods: The main Registry and the first sub-study are prospective longitudinal studies, while the second sub-study is an open-label randomised trial. 36 study centres across Nigeria have been registered and 10 of them are already recruiting subjects. Patients will be recruited from June to December 2017 and followed up till December 2018. Serum selenium and glutathione peroxidase will be assayed at recruitment for consecutive PPCM patients with LV ejection fraction (LVEF) <45% at 6 months postpartum. 200 subjects with selenium deficiency will be randomised into treatment (Selenium Selenite 200µg tablets daily for 3 months) and control arms. In the second sub-study, 120 apparently healthy pregnant women will be recruited at 28-38 weeks of gestation and reviewed at 6-8 weeks postpartum, and their serum selenium and GPO levels will be measured at recruitment.Conclusion: This will be the largest systematic evaluation of PPCM in Nigeria, and it is hoped that the information will assist in developing locally applicable treatment guidelines and policies for the disease.