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Clinical Trials/NCT04231591
NCT04231591
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country34 target enrollmentNovember 13, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Mayo Clinic
Enrollment
34
Locations
1
Primary Endpoint
Postpartum cardiac complications
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 13, 2019
End Date
December 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carl H. Rose

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postpartum cardiac complications

Time Frame: Initial 96 hours following delivery of infant(s)

Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest

Intrapartum cardiac complications

Time Frame: Inpatient admission for subsequent 48 hours

Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest

Secondary Outcomes

  • Intrapartum obstetrical complications(Inpatient admission for subsequent 48 hours)
  • Postpartum obstetrical complications(Initial 96 hours following delivery of infant(s))

Study Sites (1)

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