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Peripartum CardiomyopathyPhase 4PEACENCT03081949

Peripartum Cardiomyopathy in Nigeria Registry

A Phase 4 study testing Oral Sodium Selenite 200 µg/day for 3 months in people with Peripartum Cardiomyopathy, run by Aminu Kano Teaching Hospital at 2 sites in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Peripartum Cardiomyopathy
What is being tested?
Oral Sodium Selenite 200 µg/day for 3 months
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesNigeria
Study dates
12 Jun 2017to 31 Dec 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Nigeria2 sites

  • Aminu Kano Teaching Hospital

    Kano, 700233

  • Aminu Kano Teaching Hospital

    Kano

Other trials in Nigeria

About this study

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

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.

Read the 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:

  1. 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.

  1. 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.

Being tested
Oral Sodium Selenite 200 µg/day for 3 months
Keywords
peripartum cardiomyopathy, Ventricular remodelling, Survival, Selenium, Oxidative stress, Nigeria
Medical subject headings
Peripartum Cardiomyopathy, Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral Sodium Selenite 200 µg/day for 3 monthsDrug

    Also called Nature's way Selenium 200mcg

    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.

Study groups in NCT03081949
Study groupRoleWhat they receive
TreatmentActive comparatorOral Sodium Selenite 200 µg/day for 3 months
Receives: Drug: Oral Sodium Selenite 200 µg/day for 3 months
ControlNo interventionNo treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Over 6 months

Secondary outcomes (8)

  1. 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.

    Measured: At baseline, 3 months, 12 and 18 months of follow up.

  2. 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.

    Measured: At baseline, 3 months, 12 and 18 months of follow up.

  3. 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.

    Measured: 18 months

  4. Left Ventricular remodelling in PPCM patients

    Change in LVEF and LVEDDi to determine LVRR

    Measured: At baseline, and 6, 12 and18 months follow up

  5. 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.

    Measured: At baseline, and 6, 12 and18 months follow up

  6. Rehospitalisation rate

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

    Measured: 18 months

  7. 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.

    Measured: 18 months

  8. Survival rate

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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2017
  2. Study start12 Jun 2017
  3. Primary completion30 Jun 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03081949
Sponsor's protocol ID
version 3
Acronym
PEACE
Status last verified
Jan 2021
First submitted
22 Feb 2017
Last updated
22 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We intend to publish the results in peer reviewed scientific journals.

Publications

  • 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. doi: 10.1186/s12872-020-01739-z.

    PubMed 33087055

  • 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 4;21(1):4. doi: 10.1186/s12872-020-01782-w. No abstract available.

    PubMed 33397290

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral Sodium Selenite 200 µg/day for 3 months in people with Peripartum Cardiomyopathy, run by Aminu Kano Teaching Hospital at 2 sites in Nigeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of peripartum cardiomyopathy (PPCM) in Nigeria (time frame: Over 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03081949, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.

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