Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

Hypoplastic Left Heart Syndrome Clinical Trial

Official title:

Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03147014
• Other study ID #: MH-FCHD01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2018
• Source: Beijing Anzhen Hospital
• Contact: Yanping Ruan, MD
• Phone: +86 15311258732
• Email: yanping.ruan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

Description:

The purpose of this study is to investigate the phenomenon of cardiovascular system response to maternal hyperoxygenation in the fetus with congenital heart disease(CHD), which can provide further insight into fetal adaptations to CHD and improve our understanding of the pathophysiology of these conditions.Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography various gestational weeks.The baseline fetal echocardiography parameters has obtained from these gravidas.Then the participants received 10-15 minutes hyperoxygenation, and the accordingly fetal echocardiography parameters were obtained.The objective of the study includes:(1)To investigate the response of the MCA PI to maternal hyperoxygenation in various forms of CHD. Middle cerebral artery(MCA) pulsatility index (PI) at MH will be compared to baseline at various gestational ages in a variety of types of CHD;(2)To investigate the response of the umbilical artery (UA) PI to maternal hyperoxygenation in various forms of CHD. UA PI at MH will be compared to baseline at various gestational ages in a variety of CHD; (3)To study the response of myocardial diastolic function to MH in various forms of CHD. Diastolic inflow patterns across the tricuspid and mitral valves will be measured and ductus venosus flow pattern will be evaluated at MH and compared to baseline at various gestational ages in a variety of CHD;(4)To investigate for any changes in cardiac output and the ratio of flow between the right and left ventricles in response to MH in various forms of CHD;(5)To investigate for changes in flow pattern at the aortic isthmus in those with suspicion or clear evidence of coarctation of the aorta.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All singleton fetuses with CHD at all gestational ages are eligible for enrollment in the study. Patients will be recruited to enroll in the study as they present for clinical care at Fetal Echocardiography clinic. MH assessments will all be performed only at the Beijing Anzhen Hospital. Baseline room air data for CHD may be collected from other referring centers within the Anzhen network.

Exclusion Criteria:

• Non-sinus rhythm, presence of arrhythmia; Fetal hydrops; Severe brain anomaly (which may influence MCA flow); Evidence for significant ventricular dysfunction; Evidence for constriction of the ductus arteriosus

Related Conditions & MeSH terms

• Aneurysm
• Aortic Coarctation
• Atrial Septal Aneurysm
• Heart Defects, Congenital
• Heart Diseases
• Hypoplastic Left Heart Syndrome

Intervention

Biological:
• Maternal hyperoxygenation
approximately 10-15 minutes of maternal hyperoxygenation

Locations

Country	Name	City	State
China	Beijng Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Response of myocardial diastolic function to MH in various forms of CHD	Diastolic inflow patterns across the tricuspid and mitral valves will be measured and ductus venosus flow pattern will be evaluated at MH and compared to baseline at various gestational ages in a variety of CHD.	10-15 minutes
Other	Systolic function change before and after MH	any changes in cardiac output and the ratio of flow between the right and left ventricles in response to MH in various forms of CHD.	10-15 minutes
Other	Changes in flow pattern at the aortic isthmus	Changes in flow pattern at the aortic isthmus in those with suspicion or clear evidence of coarctation of the aorta	10-15 minutes
Primary	MCA PI change before and after maternal hyperoxygenation	The response of the MCA PI to maternal hyperoxygenation in various forms of CHD. MCA PI at MH will be compared to baseline at various gestational ages in a variety of types of CHD.	10-15 minutes
Secondary	UA PI change before and after maternal hyperoxygenation	Response of the umbilical artery (UA) PI to maternal hyperoxygenation in various forms of CHD. UA PI at MH will be compared to baseline at various gestational ages in a variety of CHD.	10-15 minutes