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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04231591
Other study ID # 19-005429
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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