Congenital Heart Disease in PregnancyNCT03737006
Coxsackie Virus in Pregnancy and Congenital Heart Disease
An observational study of Congenital Heart Disease in Pregnancy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Investigators would like to find out if a woman's exposure to Coxsackievirus has an effect or increase in incidence of babies being born with congenital heart disease(CHD) Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease in Pregnancy
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 1 Dec 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant Woman whose babies have been diagnosed with CHD ( a congenital heart defect) and controls (pregnant women babies without CHD).
Who may be able to join
- Fetal echocardiogram demonstrating one of the following: Hypoplastic Left Heart Syndrome (HLHS) or variant, other congenital heart disease (OCHD), or unaffected control (UC)
- Gestation is ≥20 wks-fetal group (HLHS, OCHD)
- Subject is able and willing to give informed consent.
Who cannot join
- Subject is < 18 years of age.
- Subject is pregnant with twins or multiple gestations.
- Subject's pregnancy is affected by 3 or more congenital anomalies (in addition to the heart defect).
- Subject's pregnancy is affected by chromosomal anomalies (OCHD \& UC groups)
- Maternal history of chromosomal anomaly (OCHD \& UC groups)
- Infertility treatment for current/index pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
St Louis Childrens Hospital
St Louis, Missouri, 63110
About this study
Official title: Coxsackievirus Group B (CVB) Infection in Early Pregnancy
Investigators would like to find out if a woman's exposure to Coxsackievirus has an effect or increase in incidence of babies being born with congenital heart disease(CHD)
Read the detailed description
The investigator proposes that Coxsackievirus group B (CVB) infection in early pregnancy induces pathological changes in congenital heart defects. To test the hypothesis, it will be determined if the incidence of CVB infection in women with babies that are congenital heart defect-(CHD) affected pregnancies are higher than in control subjects.
After informed consent participants will provide the following samples during one study visit: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab) and complete a study questionnaire Our 3 study groups are the following-Group 1 is Hypoplastic Left Heart Syndrome or HLHS effected pregnancies. Group 2 is OCHD- Other Congenital Heart Defects and Group 3 is Unaffected Controls (UC) also known as healthy controls.
After informed consent participants will provide the following samples: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab).
A health history review and questionnaire will also be obtained.
Analysis of these samples(blood, stool and nose secretions), a medical history review and questionnaire data will help to determine if there is a link or increased risk of those who may be exposed to virus.
Note- Prior to April 2016- the protocol and the healthy control (HC)subjects group were enrolled to come in for three study visits at varying times in their pregnancy. Blood, nose and stool samples were obtained at all three visits.
- Conditions
- Congenital Heart Disease in Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1-(HLHS) effected pregnancies | Consent,blood draw, nose swab, stool collection,questionnaire and review of medical records. | |
| 2-Other Congenital Heart Defect (OCHD) | Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records. | |
| 3-Healthy Controls (UC) | Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal prenatal and newborn Cox B viral strand identification
Virus identification: Comparison to VP1 sequences available in GenBank will be used to identify the strain of CVB in the isolates.
Measured: 3 - 5years
Maternal prenatal and newborn Cox B antibody levels
Serum CVB antibody titers: Past or current CVB infection will be determined from titers (>/= 1:80) collected from stool, serum and a nasal swab.
Measured: 3 - 5years
Secondary outcomes (1)
Variables and trends influencing Congenital Heart Disease
Questionnaires and medical records: To account for potential confounders of CVB serology results through exploratory regression type analysis. Preliminary data is needed to investigate the relationship between variables and measured endpoints.
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Mar 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease in PregnancyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pirooz Eghtesady, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737006
- Sponsor's protocol ID
- 201602122
- Status last verified
- Aug 2022
- First submitted
- 11 Apr 2017
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tchervenkov CI, Jacobs JP, Weinberg PM, Aiello VD, Beland MJ, Colan SD, Elliott MJ, Franklin RC, Gaynor JW, Krogmann ON, Kurosawa H, Maruszewski B, Stellin G. The nomenclature, definition and classification of hypoplastic left heart syndrome. Cardiol Young. 2006 Aug;16(4):339-68. doi: 10.1017/S1047951106000291.
PubMed 16839428Hickey EJ, Caldarone CA, McCrindle BW. Left ventricular hypoplasia: a spectrum of disease involving the left ventricular outflow tract, aortic valve, and aorta. J Am Coll Cardiol. 2012 Jan 3;59(1 Suppl):S43-54. doi: 10.1016/j.jacc.2011.04.046.
PubMed 22192721Kallewaard NL, Zhang L, Chen JW, Guttenberg M, Sanchez MD, Bergelson JM. Tissue-specific deletion of the coxsackievirus and adenovirus receptor protects mice from virus-induced pancreatitis and myocarditis. Cell Host Microbe. 2009 Jul 23;6(1):91-8. doi: 10.1016/j.chom.2009.05.018.
PubMed 19616768Shi Y, Chen C, Lisewski U, Wrackmeyer U, Radke M, Westermann D, Sauter M, Tschope C, Poller W, Klingel K, Gotthardt M. Cardiac deletion of the Coxsackievirus-adenovirus receptor abolishes Coxsackievirus B3 infection and prevents myocarditis in vivo. J Am Coll Cardiol. 2009 Apr 7;53(14):1219-26. doi: 10.1016/j.jacc.2008.10.064.
PubMed 19341864Bergelson JM, Cunningham JA, Droguett G, Kurt-Jones EA, Krithivas A, Hong JS, Horwitz MS, Crowell RL, Finberg RW. Isolation of a common receptor for Coxsackie B viruses and adenoviruses 2 and 5. Science. 1997 Feb 28;275(5304):1320-3. doi: 10.1126/science.275.5304.1320.
PubMed 9036860McBride KL, Marengo L, Canfield M, Langlois P, Fixler D, Belmont JW. Epidemiology of noncomplex left ventricular outflow tract obstruction malformations (aortic valve stenosis, coarctation of the aorta, hypoplastic left heart syndrome) in Texas, 1999-2001. Birth Defects Res A Clin Mol Teratol. 2005 Aug;73(8):555-61. doi: 10.1002/bdra.20169.
PubMed 16007587Delorme-Axford E, Donker RB, Mouillet JF, Chu T, Bayer A, Ouyang Y, Wang T, Stolz DB, Sarkar SN, Morelli AE, Sadovsky Y, Coyne CB. Human placental trophoblasts confer viral resistance to recipient cells. Proc Natl Acad Sci U S A. 2013 Jul 16;110(29):12048-53. doi: 10.1073/pnas.1304718110. Epub 2013 Jul 1.
PubMed 23818581
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coxsackievirus Group B (CVB) Infection in Early Pregnancy
- ClinicalTrials.gov ID
- NCT03737006
- Acronym / sponsor ID
- 201602122
- Conditions
- Congenital Heart Disease in Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 9 Nov 2018 (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.
Investigators would like to find out if a woman's exposure to Coxsackievirus has an effect or increase in incidence of babies being born with congenital heart disease(CHD)
Detailed description
The investigator proposes that Coxsackievirus group B (CVB) infection in early pregnancy induces pathological changes in congenital heart defects. To test the hypothesis, it will be determined if the incidence of CVB infection in women with babies that are congenital heart defect-(CHD) affected pregnancies are higher than in control subjects.
After informed consent participants will provide the following samples during one study visit: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab) and complete a study questionnaire Our 3 study groups are the following-Group 1 is Hypoplastic Left Heart Syndrome or HLHS effected pregnancies. Group 2 is OCHD- Other Congenital Heart Defects and Group 3 is Unaffected Controls (UC) also known as healthy controls.
After informed consent participants will provide the following samples: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab).
A health history review and questionnaire will also be obtained.
Analysis of these samples(blood, stool and nose secretions), a medical history review and questionnaire data will help to determine if there is a link or increased risk of those who may be exposed to virus.
Note- Prior to April 2016- the protocol and the healthy control (HC)subjects group were enrolled to come in for three study visits at varying times in their pregnancy. Blood, nose and stool samples were obtained at all three visits.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-(HLHS) effected pregnancies | – | –Consent,blood draw, nose swab, stool collection,questionnaire and review of medical records. |
| 2-Other Congenital Heart Defect (OCHD) | – | –Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records. |
| 3-Healthy Controls (UC) | – | –Consent, blood draw, nose swab, stool collection, questionnaire and review of medical records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant Woman whose babies have been diagnosed with CHD ( a congenital heart defect) and controls (pregnant women babies without CHD).
Key inclusion criteria (3 listed)
- Fetal echocardiogram demonstrating one of the following: Hypoplastic Left Heart Syndrome (HLHS) or variant, other congenital heart disease (OCHD), or unaffected control (UC)
- Gestation is ≥20 wks-fetal group (HLHS, OCHD)
- Subject is able and willing to give informed consent.
Key exclusion criteria (6 listed)
- Subject is < 18 years of age.
- Subject is pregnant with twins or multiple gestations.
- Subject's pregnancy is affected by 3 or more congenital anomalies (in addition to the heart defect).
- Subject's pregnancy is affected by chromosomal anomalies (OCHD \& UC groups)
- Maternal history of chromosomal anomaly (OCHD \& UC groups)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal prenatal and newborn Cox B viral strand identification
Time frame: 3 - 5years
Virus identification: Comparison to VP1 sequences available in GenBank will be used to identify the strain of CVB in the isolates.
Maternal prenatal and newborn Cox B antibody levels
Time frame: 3 - 5years
Serum CVB antibody titers: Past or current CVB infection will be determined from titers (>/= 1:80) collected from stool, serum and a nasal swab.
1 secondary outcome
Variables and trends influencing Congenital Heart Disease
Time frame: 3-5 years
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 4 Aug 2022.
- Background: PubMed 16839428Tchervenkov CI, Jacobs JP, Weinberg PM, Aiello VD, Beland MJ, Colan SD, Elliott MJ, Franklin RC, Gaynor JW, Krogmann ON, Kurosawa H, Maruszewski B, Stellin G. The nomenclature, definition and classification of hypoplastic left heart syndrome. Cardiol Young. 2006 Aug;16(4):339-68. doi: 10.1017/S1047951106000291.
- Background: PubMed 22192721Hickey EJ, Caldarone CA, McCrindle BW. Left ventricular hypoplasia: a spectrum of disease involving the left ventricular outflow tract, aortic valve, and aorta. J Am Coll Cardiol. 2012 Jan 3;59(1 Suppl):S43-54. doi: 10.1016/j.jacc.2011.04.046.
- Background: PubMed 19616768Kallewaard NL, Zhang L, Chen JW, Guttenberg M, Sanchez MD, Bergelson JM. Tissue-specific deletion of the coxsackievirus and adenovirus receptor protects mice from virus-induced pancreatitis and myocarditis. Cell Host Microbe. 2009 Jul 23;6(1):91-8. doi: 10.1016/j.chom.2009.05.018.
- Background: PubMed 19341864Shi Y, Chen C, Lisewski U, Wrackmeyer U, Radke M, Westermann D, Sauter M, Tschope C, Poller W, Klingel K, Gotthardt M. Cardiac deletion of the Coxsackievirus-adenovirus receptor abolishes Coxsackievirus B3 infection and prevents myocarditis in vivo. J Am Coll Cardiol. 2009 Apr 7;53(14):1219-26. doi: 10.1016/j.jacc.2008.10.064.
- Background: PubMed 9036860Bergelson JM, Cunningham JA, Droguett G, Kurt-Jones EA, Krithivas A, Hong JS, Horwitz MS, Crowell RL, Finberg RW. Isolation of a common receptor for Coxsackie B viruses and adenoviruses 2 and 5. Science. 1997 Feb 28;275(5304):1320-3. doi: 10.1126/science.275.5304.1320.
- Background: PubMed 16007587McBride KL, Marengo L, Canfield M, Langlois P, Fixler D, Belmont JW. Epidemiology of noncomplex left ventricular outflow tract obstruction malformations (aortic valve stenosis, coarctation of the aorta, hypoplastic left heart syndrome) in Texas, 1999-2001. Birth Defects Res A Clin Mol Teratol. 2005 Aug;73(8):555-61. doi: 10.1002/bdra.20169.
- Background: PubMed 23818581Delorme-Axford E, Donker RB, Mouillet JF, Chu T, Bayer A, Ouyang Y, Wang T, Stolz DB, Sarkar SN, Morelli AE, Sadovsky Y, Coyne CB. Human placental trophoblasts confer viral resistance to recipient cells. Proc Natl Acad Sci U S A. 2013 Jul 16;110(29):12048-53. doi: 10.1073/pnas.1304718110. Epub 2013 Jul 1.
- Individual participant dataSharing planned: Undecided
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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.
Pirooz Eghtesady, MD principal investigator
Washington University School of Medicine
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 in Pregnancy, run by Washington University School of Medicine 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 3 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 4 Aug 2022. 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?
Maternal prenatal and newborn Cox B viral strand identification (time frame: 3 - 5years). 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?
On the ClinicalTrials.gov record for NCT03737006, which also lists 7 linked publications.
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 4 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.