Clinical Trials Directory

Trials / Completed

CompletedNCT04231591

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

Status
Completed
Phase
Study type
Observational
Enrollment
34 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTNT-proBNPCollect 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.

Timeline

Start date
2019-11-13
Primary completion
2023-12-01
Completion
2023-12-01
First posted
2020-01-18
Last updated
2024-03-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04231591. Inclusion in this directory is not an endorsement.