A Study of Pregnancy Outcomes in Congenital Heart Disease

• Conditions: Congenital Heart Disease

• Registration Number: NCT06678256
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18
• Study Start: 2025-08-01
• Primary Completion: 2026-11
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Congenital Heart Disease Diagnosis
• Currently Pregnant

Exclusion Criteria

• Unable to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Subjects with cardiovascular adverse events	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subject Deaths	Baseline	Death will be determined as death due to end-stage heart failure, sudden cardiac death, thromboembolic death, and noncardiac death

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States