NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients

Completed

• Conditions: Pregnancy Complications; Congenital Heart Disease
• Interventions: Diagnostic Test: NT-proBNP

• Registration Number: NCT04231591
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to determine if NT-BNP levels obtained at time of admission for delivery are predictive of intrapartum or postpartum complications in patients with adult congenital heart disease.

Detailed Description

Amino-terminal pro-B-type natiuretic peptide (NT-proBNP) is a prohormone released from cardiac ventricular myocytes in direct response to cardiac workload. Secreted in the biologically inactive form, NT-proBNP is cleaved in the circulation into BNP, which subsequently exerts both vasodilatory and diuretic effects. The principal clinical utility of serum NT-proBNP measurement has been as an adjunctive marker in the diagnosis of subclinical heart failure, with higher levels typically reflective of increasing cardiac dysfunction.

The proposed prospective cohort study intends to collect serum NT-proBNP levels in singleton ACHD patients and a comparative normotensive control group at time of admission for delivery to characterize negative predictive values for intrapartum and postpartum cardiac events. Both pregnant patients with previously-diagnosed ACHD and those diagnosed and delivering during the study interval will be candidates for participation, and a gestational age threshold of 37 weeks will be utilized for the control group.

Study Timeline

• Study First Submitted: 2019-11-12
• Study Start: 2019-11-13
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

• Pregnant adult women ages 18 - 50
• Pregnancy with congenital heart disease (study group) or without congenital heart disease (control group)

Exclusion Criteria

• Non-pregnant patients
• Non-English-speaking patients
• Maternal age <18 years or >50 years
• Patients with hypertensive complications of pregnancy
• Maternal peripartum cardiomyopathy
• Multiple gestation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACDH Pregnancy - Study group	NT-proBNP	Pregnant women with known adult congenital heart disease.
Uncomplicated pregnancy - Control group	NT-proBNP	Healthy women with an uncomplicated pregnancy

Primary Outcome Measures

Name	Time	Method
Postpartum cardiac complications	Initial 96 hours following delivery of infant(s)	Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest
Intrapartum cardiac complications	Inpatient admission for subsequent 48 hours	Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest

Secondary Outcome Measures

Name	Time	Method
Intrapartum obstetrical complications	Inpatient admission for subsequent 48 hours	Incidence of preeclampsia or gestational hypertension, incidence of placental abruption, cesarean section rate
Postpartum obstetrical complications	Initial 96 hours following delivery of infant(s)	Incidence of postpartum hemorrhage, incidence of venous thromboembolism

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States