Peripartum Cardiomyopathy in Nigeria Registry (PEACE)
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|ClinicalTrials.gov Identifier: NCT03081949|
Recruitment Status : Active, not recruiting
First Posted : March 17, 2017
Last Update Posted : July 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripartum Cardiomyopathy||Drug: Oral Sodium Selenite 200 µg/day for 3 months||Phase 4|
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.
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 (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||June 12, 2017|
|Actual Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 2019|
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 Name: Nature's way Selenium 200mcg
No Intervention: Control
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- Rehospitalisation rate [ Time Frame: 18 months ]Number of participants who experience hospitalization for any cardiovascular disease during follow up.
- 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.
- Survival rate [ Time Frame: 18 months ]Number of participants who have survived the follow-up period of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081949
|Aminu Kano Teaching Hospital|
|Kano, Nigeria, 700233|
|Aminu Kano Teaching Hospital|
|Principal Investigator:||Kamilu M Karaye, PhD||Aminu Kano Teaching Hospital, Kano|