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

Mayo Clinic

Status: Completed

Conditions: Pregnancy Complications; Congenital Heart Disease

Treatments: Diagnostic Test: NT-proBNP

Study type: Observational

Funder types: Other

Identifiers

NCT04231591

19-005429

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

34 participants in 2 patient groups

ACDH Pregnancy - Study group

Description:

Pregnant women with known adult congenital heart disease.

Treatment:

Diagnostic Test: NT-proBNP

Uncomplicated pregnancy - Control group

Description:

Healthy women with an uncomplicated pregnancy

Treatment:

Diagnostic Test: NT-proBNP