Clinical trial NCT03081949: Peripartum Cardiomyopathy in Nigeria Registry
Official title: Peripartum Cardiomyopathy in Nigeria (PEACE) A Registry to Study the Demographics, Social and Clinical Characteristics, Pathophysiology and Outcomes of Peripartum Cardiomyopathy in Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripartum Cardiomyopathy
Keywords: peripartum cardiomyopathy
Ventricular remodelling
Survival
Selenium
Oxidative stress
Nigeria
Lead sponsor: Aminu Kano Teaching Hospital
Sponsor class: OTHER
Collaborators: name: Nigerian Cardiac Society
First posted: 2017-03-17
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Prevalence of peripartum cardiomyopathy (PPCM) in Nigeria
timeFrame: Over 6 months
Secondary outcomes:
measure: Selenium deficiency in PPCM patients and apparently healthy pregnant women in Nigeria
timeFrame: At baseline, 3 months, 12 and 18 months of follow up.
measure: Oxidative stress in PPCM patients and apparently healthy pregnant women in Nigeria
timeFrame: At baseline, 3 months, 12 and 18 months of follow up.
measure: The effect of sodium selenite supplementation on cardiac function among PPCM patients.
timeFrame: 18 months
measure: Left Ventricular remodelling in PPCM patients
timeFrame: At baseline, and 6, 12 and18 months follow up
measure: Right Ventricular (RV) remodelling in PPCM patients
timeFrame: At baseline, and 6, 12 and18 months follow up
measure: Rehospitalisation rate
timeFrame: 18 months
measure: Prevalence of cardio-embolic events
timeFrame: 18 months
measure: Survival rate
timeFrame: 18 months
Other outcomes:
Locations:
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
Study officials:
affiliation: Aminu Kano Teaching Hospital, Kano
name: Kamilu M Karaye, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karaye KM, Sa'idu H, Balarabe SA, Ishaq NA, Sanni B, Abubakar H, Mohammed BL, Abdulsalam T, Tukur J, Mohammed IY. Selenium supplementation in patients with peripartum cardiomyopathy: a proof-of-concept trial. BMC Cardiovasc Disord. 2020 Oct 21;20(1):457. doi: 10.1186/s12872-020-01739-z.
citation: Karaye KM, Sa'idu H, Balarabe SA, Ishaq NA, Sanni B, Abubakar H, Mohammed BL, Abdulsalam T, Tukur J, Mohammed IY. Correction to: Selenium supplementation in patients with peripartum cardiomyopathy: a proof-of-concept trial. BMC Cardiovasc Disord. 2021 Jan 4;21(1):4. doi: 10.1186/s12872-020-01782-w. No abstract available.