Hypoplastic Left Heart SyndromeNCT03147014
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
A study testing Maternal hyperoxygenation in people with Hypoplastic Left Heart Syndrome and Aortic Coarctation, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoplastic Left Heart Syndrome, Aortic Coarctation, Atrial Septal Aneurysm
- What is being tested?
- Maternal hyperoxygenation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2022
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijng Anzhen Hospital
Beijing, Beijing Municipality, 100029
Wei Li, MD, +86 15901281629, anzhenyuanban@163.com
About this study
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Read the detailed 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.
- Being tested
- Maternal hyperoxygenation
- Keywords
- Echocardiography, Congenital Heart Disease, Maternal hyperoxygenation
- Medical subject headings
- Hypoplastic Left Heart Syndrome, Aortic Coarctation, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal hyperoxygenationBiological
approximately 10-15 minutes of maternal hyperoxygenation
| Study group | Role | What they receive |
|---|---|---|
| Maternal Hyperoxygenation | Other | Maternal hyperoxygenation will be offered by administering 10 liters nasal cannula by face-mask (approximately 60% fiO2) for a minimum of 10 minutes. Receives: Biological: Maternal hyperoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-15 minutes
Secondary outcomes (1)
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.
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoplastic Left Heart SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Yihua,MD, Beijing Anzhen Hospital
- Investigators
- Yihua He, MD, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147014
- Sponsor's protocol ID
- MH-FCHD01
- Status last verified
- Dec 2018
- First submitted
- 4 May 2017
- Last updated
- 4 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03147014
- Acronym / sponsor ID
- MH-FCHD01
- Keywords
- Echocardiography, Congenital Heart Disease, Maternal hyperoxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 May 2017 (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.
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maternal Hyperoxygenation | Other | Biological: Maternal hyperoxygenationMaternal hyperoxygenation will be offered by administering 10 liters nasal cannula by face-mask (approximately 60% fiO2) for a minimum of 10 minutes. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Maternal hyperoxygenationapproximately 10-15 minutes of maternal hyperoxygenation | Biological | Maternal Hyperoxygenation |
Primary outcome
MCA PI change before and after maternal hyperoxygenation
Time frame: 10-15 minutes
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.
1 secondary outcome
UA PI change before and after maternal hyperoxygenation
Time frame: 10-15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
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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.
Yihua He, MD study director
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal hyperoxygenation in people with Hypoplastic Left Heart Syndrome and Aortic Coarctation, run by Beijing Anzhen Hospital at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Dec 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanping Ruan, MD (+86 15311258732, yanping.ruan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCA PI change before and after maternal hyperoxygenation (time frame: 10-15 minutes). 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 4 Dec 2018.