Clinical trial NCT04231591: NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients
Official title: NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Pregnancy Complications
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Intrapartum cardiac complications
timeFrame: Inpatient admission for subsequent 48 hours
measure: Postpartum cardiac complications
timeFrame: Initial 96 hours following delivery of infant(s)
Secondary outcomes:
measure: Intrapartum obstetrical complications
timeFrame: Inpatient admission for subsequent 48 hours
measure: Postpartum obstetrical complications
timeFrame: Initial 96 hours following delivery of infant(s)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Carl H. Rose, M.D.
role: PRINCIPAL_INVESTIGATOR
References: