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NCT04769167: CHARMED
Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes
NA trial testing Stool and Blood Specimen Collection in Congenital Heart Disease in 114 participants. Completed in 5 December 2023.
5 December 2023
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | factorial |
| Masking | single |
| Primary purpose | screening |
| Enrollment | 114 |
| Start date | 1 February 2021 |
| Primary completion | 5 December 2023 |
| Estimated completion | 5 December 2023 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Stool and Blood Specimen Collection
- Follow-up Medical Record Review
Conditions studied
- Congenital Heart Disease — all drugs for Congenital Heart Disease →
- Viremia — all drugs for Viremia →
- Virus Diseases — all drugs for Virus Diseases →
- Enterovirus — all drugs for Enterovirus →
Sponsor
Washington University School of Medicine
Who can join
Adults 18 to 45, female only, with Congenital Heart Disease or Viremia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Beyond EV-B, there are clinical observations to implicate other viruses in birth defects, including CHD. Since the Rubella epidemic of 1960s', however, viruses have received little attention and certainly no comprehensive study, especially using next generation sequencing (NGS), has been undertaken in this context. The current pandemic as well as those caused by Zika, influenza, Ebola and Lassa Fever (among many) have shown pregnant women and their baby are at high risk. Therefore, an open-minded approach is warranted when considering the role of maternal viral infections in CHD. Even less is known about maternal immune response, such as antibody production, to these viruses. The investigator's goal is to answer the above gaps in knowledge. The investigators propose to do that using two different approaches; one retrospective (analysis of samples in two existing, large biorepositories) and the other prospective. The investigator's have created a multi-disciplinary team to bring together the needed expertise from individuals who have overlapping and vested interest in this project. The investigator's specific aim is to examine the diversity of the gut virome in non-pregnant and pregnant women with and without diabetes, with special emphasis on known cardiotropic viruses (those with tropism for cardiac tissues). This study is seen by the investigator's as the first step prior to a larger prospective multi-institutional study to specifically assess the linkage between the maternal virome and CHD pathogenesis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04769167
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Washington University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04769167 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
- Last refreshed: 24 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04769167.
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