Peripartum Cardiomyopathy in Nigeria (PEACE) A Registry to Study the Demographics, Social and Clinical Characteristics, Pathophysiology and Outcomes of Peripartum Cardiomyopathy in Nigeria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of peripartum cardiomyopathy (PPCM) in Nigeria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment
Oral Sodium Selenite 200 µg/day for 3 months
干预措施: Oral Sodium Selenite 200 µg/day for 3 months (Drug)
结局指标
主要结局
Prevalence of peripartum cardiomyopathy (PPCM) in Nigeria
时间窗: Over 6 months
All participants confirmed to have PPCM presenting to the study centres, as described in PEACE Registry protocol V3.
次要结局
- Oxidative stress in PPCM patients and apparently healthy pregnant women in Nigeria(At baseline, 3 months, 12 and 18 months of follow up.)
- The effect of sodium selenite supplementation on cardiac function among PPCM patients.(18 months)
- Left Ventricular remodelling in PPCM patients(At baseline, and 6, 12 and18 months follow up)
- Rehospitalisation rate(18 months)
- Selenium deficiency in PPCM patients and apparently healthy pregnant women in Nigeria(At baseline, 3 months, 12 and 18 months of follow up.)
- Right Ventricular (RV) remodelling in PPCM patients(At baseline, and 6, 12 and18 months follow up)
- Prevalence of cardio-embolic events(18 months)
- Survival rate(18 months)
研究者
Prof Kamilu Karaye
Professor and Honorary Consultant
Aminu Kano Teaching Hospital