Peripartum Cardiomyopathy in Nigeria Registry

NCT03081949 | Completed Phase 4

• 1 other identifier: version 3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripartum Cardiomyopathy

Keywords

peripartum cardiomyopathy; Ventricular remodelling; Survival; Selenium; Oxidative stress; Nigeria

Outcome Measures

Primary Outcomes (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.

  Over 6 months

Secondary Outcomes (8)

• Selenium deficiency in PPCM patients and apparently healthy pregnant women in Nigeria

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

• Oxidative stress in PPCM patients and apparently healthy pregnant women in Nigeria

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

• The effect of sodium selenite supplementation on cardiac function among PPCM patients.

  18 months

• Left Ventricular remodelling in PPCM patients

  At baseline, and 6, 12 and18 months follow up

• Right Ventricular (RV) remodelling in PPCM patients

  At baseline, and 6, 12 and18 months follow up

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Oral Sodium Selenite 200 µg/day for 3 months

Drug: Oral Sodium Selenite 200 µg/day for 3 months

Control

NO INTERVENTION

No treatment

Interventions

Oral Sodium Selenite 200 µg/day for 3 months DRUG

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.

Also known as: Nature's way Selenium 200mcg

Treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aminu Kano Teaching Hospital: lead
• Nigerian Cardiac Society: collaborator

Study Sites (2)

Aminu Kano Teaching Hospital

Kano, 700233, Nigeria

Location

Aminu Kano Teaching Hospital

Kano, Nigeria

Location

Related Publications (2)

• 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.

  PMID: 33087055 RESULT

• 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.

  PMID: 33397290 RESULT

MeSH Terms

Conditions

Peripartum Cardiomyopathy; Ventricular Remodeling

Interventions

Sodium Selenite

Condition Hierarchy (Ancestors)

Pregnancy Complications, Cardiovascular; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Selenious Acid; Selenium Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kamilu M Karaye, PhD

  Aminu Kano Teaching Hospital, Kano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Honorary Consultant

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 17, 2017
• Study Start: June 12, 2017
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NG (2)