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

NCT04231591 | Completed

• 1 other identifier: 19-005429
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Pregnancy Complications

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Intrapartum obstetrical complications

  Inpatient admission for subsequent 48 hours

• Postpartum obstetrical complications

  Initial 96 hours following delivery of infant(s)

Study Arms (2)

ACDH Pregnancy - Study group

Pregnant women with known adult congenital heart disease.

Diagnostic Test: NT-proBNP

Uncomplicated pregnancy - Control group

Healthy women with an uncomplicated pregnancy

Diagnostic Test: NT-proBNP

Interventions

NT-proBNP DIAGNOSTIC_TEST

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.

ACDH Pregnancy - Study group; Uncomplicated pregnancy - Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Pregnant adult women ages 18 - 50
• Pregnancy with congenital heart disease (study group) or without congenital heart disease (control group)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Defects, Congenital; Pregnancy Complications

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Carl H. Rose, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: January 18, 2020
• Study Start: November 13, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

US (1)