PEACE: Peripartum Cardiomyopathy in Nigeria Registry

Sponsor

Aminu Kano Teaching Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03081949

Collaborator

Nigerian Cardiac Society (Other)

100

Enrollment

Locations

Arms

30.6

Actual Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripartum Cardiomyopathy	Drug: Oral Sodium Selenite 200 µg/day for 3 months	Phase 4

Detailed Description

To describe the burden and demographic, social and clinical characteristics of PPCM in Nigeria.
To describe the ventricular remodelling and outcomes (rehospitalisation rate, cardio-embolic events and survival) of PPCM in Nigeria.

Sub-study:

To study the relationship between selenium deficiency, oxidative stress and PPCM in Nigeria.
To describe the prevalence of selenium deficiency and its relationship with cardiac function in apparently healthy pregnant women in Nigeria.
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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 12, 2017

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/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
No Intervention: Control No treatment

Arm

Intervention/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

No Intervention: Control

No treatment

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Selenium deficiency in PPCM patients and apparently healthy pregnant women in Nigeria [At baseline, 3 months, 12 and 18 months of follow up.]
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.
Oxidative stress in PPCM patients and apparently healthy pregnant women in Nigeria [At baseline, 3 months, 12 and 18 months of follow up.]
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.
The effect of sodium selenite supplementation on cardiac function among PPCM patients. [18 months]
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.
Left Ventricular remodelling in PPCM patients [At baseline, and 6, 12 and18 months follow up]
Change in LVEF and LVEDDi to determine LVRR
Right Ventricular (RV) remodelling in PPCM patients [At baseline, and 6, 12 and18 months follow up]
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.
Rehospitalisation rate [18 months]
Number of participants who experience hospitalization for any cardiovascular disease during follow up.
Prevalence of cardio-embolic events [18 months]
Number of participants who experience stroke, transient ischemic attack or any gangrene during the follow-up period of the study.
Survival rate [18 months]
Number of participants who have survived the follow-up period of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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