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NCT Number: NCT03081949

Peripartum Cardiomyopathy in Nigeria Registry

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.

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Key information

Conditions

Peripartum Cardiomyopathy Cardiomyopathies Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Complications, Cardiovascular Urogenital Diseases Ventricular Remodeling

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aminu Kano Teaching Hospital, Kano, Nigeria

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Sodium Selenite 200 µg/day for 3 months

Drug

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

Primary outcomes

  1. Prevalence of peripartum cardiomyopathy (PPCM) in Nigeria

    Time frame: Over 6 months

    All participants confirmed to have PPCM presenting to the study centres, as described in PEACE Registry protocol V3.

Secondary outcomes

  1. Selenium deficiency in PPCM patients and apparently healthy pregnant women in Nigeria

    Time frame: 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.

  2. Oxidative stress in PPCM patients and apparently healthy pregnant women in Nigeria

    Time frame: 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.

  3. The effect of sodium selenite supplementation on cardiac function among PPCM patients.

    Time frame: 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.

  4. Left Ventricular remodelling in PPCM patients

    Time frame: At baseline, and 6, 12 and18 months follow up

    Change in LVEF and LVEDDi to determine LVRR

  5. Right Ventricular (RV) remodelling in PPCM patients

    Time frame: 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.

  6. Rehospitalisation rate

    Time frame: 18 months

    Number of participants who experience hospitalization for any cardiovascular disease during follow up.

  7. Prevalence of cardio-embolic events

    Time frame: 18 months

    Number of participants who experience stroke, transient ischemic attack or any gangrene during the follow-up period of the study.

  8. Survival rate

    Time frame: 18 months

    Number of participants who have survived the follow-up period of the study.

Sponsors and collaborators

Lead sponsor

Aminu Kano Teaching Hospital

Other

Collaborators

  • Nigerian Cardiac Society

Registry information

Official study title

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

Acronym: PEACE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2017
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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