Congenital Heart DiseaseNT-proBNPNCT04231591
NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients
An observational study of Congenital Heart Disease and Pregnancy Complications, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Congenital Heart Disease, Pregnancy Complications
- What is being tested?
- NT-proBNP
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Pregnant adult women ages 18 - 50
- Pregnancy with congenital heart disease (study group) or without congenital heart disease (control group)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Congenital Heart Disease, Pregnancy Complications
- Being tested
- NT-proBNP
- Medical subject headings
- Heart Defects, Congenital, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-proBNPDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| ACDH Pregnancy - Study group | Pregnant women with known adult congenital heart disease. Receives: Diagnostic Test: NT-proBNP | |
| Uncomplicated pregnancy - Control group | Healthy women with an uncomplicated pregnancy Receives: Diagnostic Test: NT-proBNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrapartum cardiac complications
Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest
Measured: Inpatient admission for subsequent 48 hours
Postpartum cardiac complications
Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest
Measured: Initial 96 hours following delivery of infant(s)
Secondary outcomes (2)
Intrapartum obstetrical complications
Incidence of preeclampsia or gestational hypertension, incidence of placental abruption, cesarean section rate
Measured: Inpatient admission for subsequent 48 hours
Postpartum obstetrical complications
Incidence of postpartum hemorrhage, incidence of venous thromboembolism
Measured: Initial 96 hours following delivery of infant(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start13 Nov 2019
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl H. Rose, Mayo Clinic
- Investigators
- Carl H. Rose, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231591
- Sponsor's protocol ID
- 19-005429
- Acronym
- NT-proBNP
- Status last verified
- Mar 2024
- First submitted
- 12 Nov 2019
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients
- ClinicalTrials.gov ID
- NCT04231591
- Acronym / sponsor ID
- NT-proBNP / 19-005429
- Conditions
- Congenital Heart Disease, Pregnancy Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACDH Pregnancy - Study group | – | Diagnostic Test: NT-proBNPPregnant women with known adult congenital heart disease. |
| Uncomplicated pregnancy - Control group | – | Diagnostic Test: NT-proBNPHealthy women with an uncomplicated pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Pregnant adult women ages 18 - 50
- Pregnancy with congenital heart disease (study group) or without congenital heart disease (control group)
Key exclusion criteria (6 listed)
- Non-pregnant patients
- Non-English-speaking patients
- Maternal age <18 years or >50 years
- Patients with hypertensive complications of pregnancy
- Maternal peripartum cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-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. | Diagnostic test | ACDH Pregnancy - Study group, Uncomplicated pregnancy - Control group |
Primary outcome
Intrapartum cardiac complications
Time frame: Inpatient admission for subsequent 48 hours
Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest
Postpartum cardiac complications
Time frame: Initial 96 hours following delivery of infant(s)
Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest
2 secondary outcomes
Intrapartum obstetrical complications
Time frame: Inpatient admission for subsequent 48 hours
Postpartum obstetrical complications
Time frame: Initial 96 hours following delivery of infant(s)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl H. Rose, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Pregnancy Complications, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrapartum cardiac complications (time frame: Inpatient admission for subsequent 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.