Peripartum Cardiomyopathy in Nigeria Registry (PEACE)

Peripartum Cardiomyopathy in Nigeria (PEACE) A Registry to Study the Demographics, Social and Clinical Characteristics, Pathophysiology and Outcomes of Peripartum Cardiomyopathy in Nigeria

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.

Study Overview

• Status: Completed
• Conditions: Peripartum Cardiomyopathy
• Intervention / Treatment: Drug: Oral Sodium Selenite 200 µg/day for 3 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nigeria
  • Kano, Nigeria
    • Aminu Kano Teaching Hospital
  • Kano, Nigeria, 700233
    • Aminu Kano Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No treatment
Active Comparator: Treatment; Oral Sodium Selenite 200 µg/day for 3 months	Drug: Oral Sodium Selenite 200 µg/day for 3 months; PPCM patients with selenium deficiency, who have not achieved LV reverse remodelling (LVRR) (LV end-diastolic dimension indexed to body surface area (LVEDDi) ≤33.0 mm/m2) at 6 months after diagnosis.; Other Names: Nature's way Selenium 200mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of peripartum cardiomyopathy (PPCM) in Nigeria	All participants confirmed to have PPCM presenting to the study centres, as described in PEACE Registry protocol V3.	Over 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Selenium deficiency in PPCM patients and apparently healthy pregnant women in Nigeria	Prevalence of selenium deficiency will be assessed. Serum selenium will be measured as described in PEACE Registry protocol V3. Selenium deficiency will be defined as serum selenium <70μg/L.	At baseline, 3 months, 12 and 18 months of follow up.
Oxidative stress in PPCM patients and apparently healthy pregnant women in Nigeria	Prevalence of oxidative stress will be assessed. Serum malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidise (GPO) and N-terminal pro-B-type natriuretic peptide (NT-BNP) will be measured as described in PEACE Registry protocol V3. Abnormal oxidative stress will be defined as the presence of serum NT-BNP >125pg/mL and ANY of the following: plasma MDA >1.25μmol/L, serum SOD >110ng/mL and plasma GPO >470U/L.	At baseline, 3 months, 12 and 18 months of follow up.
The effect of sodium selenite supplementation on cardiac function among PPCM patients.	PPCM patients with selenium deficiency, left ventricular ejection fraction (LVEF) <35% and/or insignificant left ventricular reverse remodeling (LVRR) at 6 months postpartum, will be offered sodium selenite 200mcg daily for 3 months, in an open-label randomized trial. LVRR would be defined as the presence of both absolute increase in LVEF ≥10.0% and decrease in LV end-diastolic dimension indexed to body surface area (LVEDDi) ≤33.0 mm/m2, while recovered LV systolic function as LVEF ≥55%, during the follow-up. Change in LVEF and LVEDDi will be measured at 6, 12, and 18 months follow up visits, to determine prevalence of LVRR among partipants on selenium treatment and those who will not be on selenium treatment.	18 months
Left Ventricular remodelling in PPCM patients	Change in LVEF and LVEDDi to determine LVRR	At baseline, and 6, 12 and18 months follow up
Right Ventricular (RV) remodelling in PPCM patients	Change in RV fractional area change (RVFAC) of the right ventricle (in cm2), to determine RV reverse remodelling (RVRR). RVRR is defined as RVFAC >35cm2.	At baseline, and 6, 12 and18 months follow up
Rehospitalisation rate	Number of participants who experience hospitalization for any cardiovascular disease during follow up.	18 months
Prevalence of cardio-embolic events	Number of participants who experience stroke, transient ischemic attack or any gangrene during the follow-up period of the study.	18 months
Survival rate	Number of participants who have survived the follow-up period of the study.	18 months

Collaborators and Investigators

• Sponsor: Aminu Kano Teaching Hospital
• Collaborators: Nigerian Cardiac Society
• Investigators: Principal Investigator: Kamilu M Karaye, PhD, Aminu Kano Teaching Hospital, Kano

Publications and helpful links

General Publications

• 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. Erratum In: BMC Cardiovasc Disord. 2021 Jan 4;21(1):4.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: March 11, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Oxidative stress; Survival; Selenium; Nigeria; peripartum cardiomyopathy; Ventricular remodelling
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Selenious Acid; Sodium Selenite; Selenium
• Other Study ID Numbers: version 3 (Protocol Version)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We intend to publish the results in peer reviewed scientific journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No