NCT06678256

Brief Summary

The purpose of this study is to determine if a biomarker assay obtained peripartum (1st-3rd trimester and post-partum) in patients with adult congenital heart disease can predict future risk of cardiovascular adverse events and determine if temporal changes in biomarkers levels throughout the peripartum period can provide a better risk prediction compared to samples taken at a single time-point.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
5mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jan 2026Nov 2026

First Submitted

Initial submission to the registry

November 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

November 5, 2024

Last Update Submit

March 17, 2026

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects with cardiovascular adverse events

    A cardiovascular adverse event is defined as Documented atrial/ventricular arrhythmias, need for cardioversion, arrhythmia-related procedures (catheter ablation, implantation of pacemaker/defibrillator, anti-arrhythmia surgery), and heart failure hospitalization.

    Baseline

Secondary Outcomes (1)

  • Number of Subject Deaths

    Baseline

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults (18+) who are currently pregnant

You may qualify if:

  • Congenital Heart Disease Diagnosis
  • Currently Pregnant

You may not qualify if:

  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alexander Egbe, MBBS, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 7, 2024

Study Start

January 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)