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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications; Congenital Heart Disease
• Intervention / Treatment: Diagnostic test: NT-proBNP

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 Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

• Study Contact: Name: Maureen A Lemens; Phone Number: 507-293-1487; Email: lemens.maureen@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This 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. A gestational age threshold of 37 weeks will be utilized for the control group.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ACDH Pregnancy - Study group; Pregnant women with known adult congenital heart disease.	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.
Uncomplicated pregnancy - Control group; Healthy women with an uncomplicated pregnancy	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Carl H. Rose, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Heart Diseases; Heart Defects, Congenital; Pregnancy Complications
• Other Study ID Numbers: 19-005429

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No