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Peripartum Cardiomyopathy in Nigeria Registry (PEACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03081949
Recruitment Status : Active, not recruiting
First Posted : March 17, 2017
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Nigerian Cardiac Society
Information provided by (Responsible Party):
Prof Kamilu Karaye, Aminu Kano Teaching Hospital

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:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 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 : June 12, 2017
Actual Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

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 Name: Nature's way Selenium 200mcg

No Intervention: Control
No treatment



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Nigeria
Aminu Kano Teaching Hospital
Kano, Nigeria, 700233
Aminu Kano Teaching Hospital
Kano, Nigeria
Sponsors and Collaborators
Aminu Kano Teaching Hospital
Nigerian Cardiac Society
Investigators
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Principal Investigator: Kamilu M Karaye, PhD Aminu Kano Teaching Hospital, Kano

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Responsible Party: Prof Kamilu Karaye, Professor and Honorary Consultant, Aminu Kano Teaching Hospital
ClinicalTrials.gov Identifier: NCT03081949     History of Changes
Other Study ID Numbers: version 3
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We intend to publish the results in peer reviewed scientific journals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof Kamilu Karaye, Aminu Kano Teaching Hospital:
peripartum cardiomyopathy
Ventricular remodelling
Survival
Selenium
Oxidative stress
Nigeria
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Selenium
Selenious Acid
Sodium Selenite
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances