Peripartum Cardiomyopathy Clinical Trial
— PEACEOfficial title:
Peripartum Cardiomyopathy in Nigeria (PEACE) A Registry to Study the Demographics, Social and Clinical Characteristics, Pathophysiology and Outcomes of Peripartum Cardiomyopathy in Nigeria
Verified date | January 2021 |
Source | Aminu Kano Teaching Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 31, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Nigeria | Aminu Kano Teaching Hospital | Kano | |
Nigeria | Aminu Kano Teaching Hospital | Kano |
Lead Sponsor | Collaborator |
---|---|
Aminu Kano Teaching Hospital | Nigerian Cardiac Society |
Nigeria,
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 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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 | |
Secondary | Left Ventricular remodelling in PPCM patients | Change in LVEF and LVEDDi to determine LVRR | At baseline, and 6, 12 and18 months follow up | |
Secondary | 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 | |
Secondary | Rehospitalisation rate | Number of participants who experience hospitalization for any cardiovascular disease during follow up. | 18 months | |
Secondary | 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 | |
Secondary | Survival rate | Number of participants who have survived the follow-up period of the study. | 18 months |
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