Peripartum Cardiomyopathy in Nigeria Registry (PEACE)

Aminu Kano Teaching Hospital

Status and phase: Completed; Phase 4

Conditions: Peripartum Cardiomyopathy

Treatments: Drug: Oral Sodium Selenite 200 µg/day for 3 months

Study type: Interventional

Funder types: Other

Identifiers

NCT03081949

version 3

Details and patient eligibility

About

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.

Full description

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. The objectives of the study are:

i. To describe the burden and demographic, social and clinical characteristics of PPCM in Nigeria.

ii. To describe the ventricular remodelling and outcomes (rehospitalisation rate, cardio-embolic events and survival) of PPCM in Nigeria.

Sub-study:

iii. To study the relationship between selenium deficiency, oxidative stress and PPCM in Nigeria.

iv. To describe the prevalence of selenium deficiency and its relationship with cardiac function in apparently healthy pregnant women in Nigeria.

v. To study the impact of sodium selenite supplementation on cardiac function among selenium deficient PPCM patients who have not recovered left ventricular function at 6 months after the diagnosis.

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, policies and interventions for this seemingly deadly disease.

Enrollment: 100 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Treatment

Active Comparator group

Description:

Oral Sodium Selenite 200 µg/day for 3 months

Treatment:

Drug: Oral Sodium Selenite 200 µg/day for 3 months

Control

No Intervention group

Description:

No treatment