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

Congenital Heart Disease Clinical Trial

— NT-proBNP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231591
• Other study ID #: 19-005429
• Status: Completed
• Start date: November 13, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Pregnancy Complications

Intervention

Diagnostic Test:
• NT-proBNP
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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrapartum cardiac complications	Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest	Inpatient admission for subsequent 48 hours
Primary	Postpartum cardiac complications	Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest	Initial 96 hours following delivery of infant(s)
Secondary	Intrapartum obstetrical complications	Incidence of preeclampsia or gestational hypertension, incidence of placental abruption, cesarean section rate	Inpatient admission for subsequent 48 hours
Secondary	Postpartum obstetrical complications	Incidence of postpartum hemorrhage, incidence of venous thromboembolism	Initial 96 hours following delivery of infant(s)