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Peripartum Cardiomyopathy in Nigeria Registry

NCT03081949 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • Peripartum Cardiomyopathy

Interventions

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.

Sponsors & Collaborators

  • Nigerian Cardiac Society

    collaborator UNKNOWN

  • Aminu Kano Teaching Hospital

    lead OTHER

Principal Investigators

  • Kamilu M Karaye, PhD · Aminu Kano Teaching Hospital, Kano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2019-06-30
Completion
2019-12-31

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081949 on ClinicalTrials.gov