CardiomyopathyNCT05438576

Screening for Pregnancy Related Heart Failure in Nigeria

A study testing Digital stethoscope electrocardiogram in people with Cardiomyopathy and Pregnancy Related, run by Mayo Clinic at 6 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

This study will evaluate the effectiveness of an artificial intelligence-enabled ECG (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria. Read more about this study

Who is it for?: Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cardiomyopathy, Pregnancy Related
What is being tested?: Digital stethoscope electrocardiogram
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,232 participants
Where: 6 sitesNigeria
Study dates: 15 Aug 2022to 15 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 49 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Currently pregnant or within 12 months postpartum
Willing and able to provide informed consent

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Nigeria6 sites

Rasheed Shekoni Specialist Hospital
Dutse, Jigawa State
University College Hospital
Ibadan, Oyo State
University of Ilorin Teaching Hospital
Ilorin, Kwara State
Aminu Kano Teaching Hospital
Kano
Lagos University Teaching Hospital
Lagos
Olabisi Onabanjo University Teaching Hospital
Sagamu, Ogun State

Other trials in Nigeria

About this study

Official title: Screening for Peripartum Cardiomyopathies Using Artificial Intelligence (SPEC-AI) in Nigeria

This study will evaluate the effectiveness of an artificial intelligence-enabled ECG (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria.

Conditions: Cardiomyopathy, Pregnancy Related
Being tested: Digital stethoscope electrocardiogram
Keywords: Cardiomyopathy, Artificial Intelligence, Women's Health, Digital Health
Medical subject headings: Cardiomyopathies

What participants receive

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

Digital stethoscope electrocardiogramOther
Digital stethoscope artificial intelligence enabled electrocardiogram (AI-ECG). An artificial intelligence algorithm which analyses ECG data and generates prediction probabilities for a diagnosis of cardiomyopathy.

Study groups in NCT05438576
Study group	Role	What they receive
Intervention	Experimental	Participants will have ECGs analyzed with artificial intelligence for cardiomyopathy detection. Receives: Other: Digital stethoscope electrocardiogram
Control	No intervention	Participants will have standard clinical ECGs acquired.

What is being measured

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

Left Ventricular Ejection Fraction (LVEF) <50%
Number of participants diagnosed with left ventricular ejection fraction (LVEF) <50% by echocardiography during pregnancy or within 12 months postpartum.
Measured: 18 months

Secondary outcomes (4)

Effectiveness of AI-ECG for Cardiomyopathy Detection in the Intervention Arm for Left Ventricular Ejection Fraction (LVEF) ≤ 35%
This is defined as a positive point-of-care AI prediction for LVEF ≤ 35% (maximum prediction across all stethoscope recording locations) confirmed with echocardiography
Measured: 18 months
Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 40%
This is defined as a positive point-of-care AI prediction for LVEF < 40% (maximum prediction across all stethoscope recording locations) confirmed with echocardiography
Measured: 18 months
Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 45%
This is defined as a positive point-of-care AI prediction for LVEF <45% (maximum prediction across all stethoscope recording locations) confirmed with echocardiography
Measured: 18 months
Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 50%
This is defined as a positive point-of-care AI prediction for LVEF <50% (maximum prediction across all stethoscope recording locations) confirmed with echocardiography
Measured: 18 months

Timeline

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

15 Aug 202215 May 2024

First posted30 Jun 2022
Study start15 Aug 2022
Primary completion15 May 2024
Study completion15 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CardiomyopathyStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,232 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05438576
Sponsor's protocol ID: 22-000539
Other IDs: K12AR084222, UL1TR002377
Status last verified: Apr 2025
First submitted: 24 Jun 2022
Last updated: 16 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Adedinsewo DA, Morales-Lara AC, Dugan J, Garzon-Siatoya WT, Yao X, Johnson PW, Douglass EJ, Attia ZI, Phillips SD, Yamani MH, Tobah YB, Rose CH, Sharpe EE, Lopez-Jimenez F, Friedman PA, Noseworthy PA, Carter RE. Screening for peripartum cardiomyopathies using artificial intelligence in Nigeria (SPEC-AI Nigeria): Clinical trial rationale and design. Am Heart J. 2023 Jul;261:64-74. doi: 10.1016/j.ahj.2023.03.008. Epub 2023 Mar 25.
PubMed 36966922
Adedinsewo DA, Morales-Lara AC, Afolabi BB, Kushimo OA, Mbakwem AC, Ibiyemi KF, Ogunmodede JA, Raji HO, Ringim SH, Habib AA, Hamza SM, Ogah OS, Obajimi G, Saanu OO, Jagun OE, Inofomoh FO, Adeolu T, Karaye KM, Gaya SA, Alfa I, Yohanna C, Venkatachalam KL, Dugan J, Yao X, Sledge HJ, Johnson PW, Wieczorek MA, Attia ZI, Phillips SD, Yamani MH, Tobah YB, Rose CH, Sharpe EE, Lopez-Jimenez F, Friedman PA, Noseworthy PA, Carter RE; SPEC-AI Nigeria Investigators. Artificial intelligence guided screening for cardiomyopathies in an obstetric population: a pragmatic randomized clinical trial. Nat Med. 2024 Oct;30(10):2897-2906. doi: 10.1038/s41591-024-03243-9. Epub 2024 Sep 2.
PubMed 39223284

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction

All Cardiomyopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Screening for Peripartum Cardiomyopathies Using Artificial Intelligence (SPEC-AI) in Nigeria
ClinicalTrials.gov ID: NCT05438576
Acronym / sponsor ID: 22-000539
Conditions: Cardiomyopathy, Pregnancy Related
Keywords: Cardiomyopathy, Artificial Intelligence, Women's Health, Digital Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,232 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: 15 Aug 2022 (actual)
Primary completion: 15 May 2024 (actual)
Study completion: 15 May 2024 (actual)
First posted: 30 Jun 2022 (actual)
Results: Posted 16 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the effectiveness of an artificial intelligence-enabled ECG (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Other: Digital stethoscope electrocardiogramParticipants will have ECGs analyzed with artificial intelligence for cardiomyopathy detection.
Control	No intervention	–Participants will have standard clinical ECGs acquired.

Who may qualify

Ages: 18 to 49 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Currently pregnant or within 12 months postpartum
Willing and able to provide informed consent

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Digital stethoscope electrocardiogramDigital stethoscope artificial intelligence enabled electrocardiogram (AI-ECG). An artificial intelligence algorithm which analyses ECG data and generates prediction probabilities for a diagnosis of cardiomyopathy.	Other	Intervention

Primary outcome

Left Ventricular Ejection Fraction (LVEF) <50%
Time frame: 18 months
Number of participants diagnosed with left ventricular ejection fraction (LVEF) <50% by echocardiography during pregnancy or within 12 months postpartum.

4 secondary outcomes

Effectiveness of AI-ECG for Cardiomyopathy Detection in the Intervention Arm for Left Ventricular Ejection Fraction (LVEF) ≤ 35%
Time frame: 18 months
Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 40%
Time frame: 18 months
Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 45%
Time frame: 18 months
Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 50%
Time frame: 18 months

Results and safety

Results posted to the registry on 16 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	616	587
Control	616	608

Primary outcome: Left Ventricular Ejection Fraction (LVEF) <50%

Time frame: 18 months. Count of participants. Unit: Participants

Measure	Intervention n = 587	Control n = 608
Pregnant	3	1
Post partum	21	11

Intervention vs Control: Odds Ratio (OR): 2.12 (95% CI 1.05 to 4.27), p = 0.032, Regression, Logistic

Population analysed: Analysis was categorized by pregnant and post-partum participants. Total of each group equals the overall number of participants analyzed per arm.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Long-term clinical outcomes including mortality were passively tracked for all participants (for up to 18 months) beyond the duration of active trial participation. These outcomes are also described as "adverse cardiovascular events" in order to match prevailing descriptions in published literature but are completely unrelated to the study intervention. Study defined adverse events per protocol were collected for up to 3 hours following study intervention (ECG and Echo recording).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	56 of 587 (9.5%)	1 of 587 (0.2%)	12 of 587
Control	53 of 608 (8.7%)	4 of 608 (0.7%)	3 of 608

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36966922Adedinsewo DA, Morales-Lara AC, Dugan J, Garzon-Siatoya WT, Yao X, Johnson PW, Douglass EJ, Attia ZI, Phillips SD, Yamani MH, Tobah YB, Rose CH, Sharpe EE, Lopez-Jimenez F, Friedman PA, Noseworthy PA, Carter RE. Screening for peripartum cardiomyopathies using artificial intelligence in Nigeria (SPEC-AI Nigeria): Clinical trial rationale and design. Am Heart J. 2023 Jul;261:64-74. doi: 10.1016/j.ahj.2023.03.008. Epub 2023 Mar 25.
Results publication: PubMed 39223284Adedinsewo DA, Morales-Lara AC, Afolabi BB, Kushimo OA, Mbakwem AC, Ibiyemi KF, Ogunmodede JA, Raji HO, Ringim SH, Habib AA, Hamza SM, Ogah OS, Obajimi G, Saanu OO, Jagun OE, Inofomoh FO, Adeolu T, Karaye KM, Gaya SA, Alfa I, Yohanna C, Venkatachalam KL, Dugan J, Yao X, Sledge HJ, Johnson PW, Wieczorek MA, Attia ZI, Phillips SD, Yamani MH, Tobah YB, Rose CH, Sharpe EE, Lopez-Jimenez F, Friedman PA, Noseworthy PA, Carter RE; SPEC-AI Nigeria Investigators. Artificial intelligence guided screening for cardiomyopathies in an obstetric population: a pragmatic randomized clinical trial. Nat Med. 2024 Oct;30(10):2897-2906. doi: 10.1038/s41591-024-03243-9. Epub 2024 Sep 2.
Individual participant dataSharing planned: No

Related trials for Cardiomyopathy

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Demilade Adedinsewo, MD, MPH principal investigator

Mayo Clinic

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Digital stethoscope electrocardiogram in people with Cardiomyopathy and Pregnancy Related, run by Mayo Clinic at 6 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 2 inclusion and 3 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Left Ventricular Ejection Fraction (LVEF) <50% (time frame: 18 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 NCT05438576, 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 16 May 2025.