N/A
Completed N=1,232
Screening for Pregnancy Related Heart Failure in Nigeria
Cardiomyopathy · Pregnancy Related
Source: ClinicalTrials.gov NCT05438576 ↗
Enrolled (actual)
1,232
Serious AEs
9.1%
Results posted
May 2025
Primary outcomePrimary: Left Ventricular Ejection Fraction (LVEF) <50% — 3; 1; 21; 11 Participants — p=0.032
Summary
This study will evaluate the effectiveness of an artificial intelligence-enabled ECG (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Ejection Fraction (LVEF) <50% |
3; 1; 21; 11 | 0.032 sig |
| SECONDARY Effectiveness of AI-ECG for Cardiomyopathy Detection in the Intervention Arm for Left Ventricular Ejection Fraction (LVEF) ≤ 35% |
17; 458; 17; 458 | — |
| SECONDARY Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 40% |
20; 458; 20; 458 | — |
| SECONDARY Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 45% |
22; 457; 22; 457 | — |
| SECONDARY Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 50% |
22; 457; 22; 457 | — |
Eligibility Criteria
Inclusion Criteria
- Currently pregnant or within 12 months postpartum
- Willing and able to provide informed consent
Exclusion Criteria
- Complex congenital heart disease (single ventricle physiology or significant shunts with cardiac structural changes)
- Significant conduction abnormalities (ventricular pacing on recorded ECG, pacemaker dependence, or severely abnormal/bizarre QRS morphology on ECG tracings)
- Unable or unwilling to provide consent
Data sourced from ClinicalTrials.gov (NCT05438576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.