Heart Failure CongenitalNCT06039553
Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure
An observational study of Heart Failure Congenital, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The goal of this observational study is to learn about the safety and effectiveness of pulmonary artery banding(PAB) therapy in pediatric heart failure(PHF) patients. The main questions it aims to answer are: Can PAB therapy improve left ventricular(LV) function in PHF patients especially refractory PHF. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Heart Failure Congenital
- What is being tested?
- pulmonary artery banding
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- How long will I take part?
- 6 Months
- 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 Up to 14 years
- All sexes
- Child
Study population: paitent younger than 14 years of age with heart failure
Who may be able to join
- patients younger than 14 years of age
- congenital heart failure (LVEF<55%, or LVFS<25%)
Who cannot join
- single ventricle
- congenital heart disease without anatomical correction
- Patients with heart failure requiring ventricular assist or cardiac synchronization therapy
- Patients with severe pulmonary hypertension (pulmonary arterial pressure >6 Wood·U)
- Patients with severe liver and kidney failure
- Patients who are allergic to related medications
- Patients with symptomatic hypotension who cannot tolerate related drugs
- Refuse to sign the informed consent or refuse to participate in this experiment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai hospital
Beijing, Beijing Municipality, 100037
Shoujun Li, MD, +86 13501071589, drlishoujunfw@163.com
About this study
Official title: A Comprehensive Research of Pediatric Heart Failure -- A Self-control Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure
The goal of this observational study is to learn about the safety and effectiveness of pulmonary artery banding(PAB) therapy in pediatric heart failure(PHF) patients.
The main questions it aims to answer are:
- Can PAB therapy improve left ventricular(LV) function in PHF patients especially refractory PHF.
- Can the complications caused by the PAB therapy be clinically acceptable? Participants underwent PAB therapy will be required to underwent echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) follow-up before the initiation of PAB and at 1 month, 3 months, and 6 months after PAB surgery. Researchers will compare the LV function 6 months after PAB suergey and the preoperative ones to see if there is improvement.
- Conditions
- Heart Failure Congenital
- Being tested
- pulmonary artery banding
- Keywords
- congenital heart disease, pulmonary artery banding
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary artery bandingProcedure or surgery
Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Artery Banding Group | Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease. Receives: Procedure: pulmonary artery banding |
What is being measured
The primary outcome is the main question the study is designed to answer.
the recurrence rate of heart failure
During follow-up visits, echocardiographic examination is conducted to measure the left ventricular function. If LVEF falls under 55%, it is recorded as a recurrence.
Measured: after 6 months of PAB surgery
Secondary outcomes (3)
NT-proBNP level
The trend in NT-proBNP levels.
Measured: after 6 months of PAB surgery
Incidence rate of drug adverse reactions
The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
Measured: after 6 months of PAB surgery
Readmission rate for heart failure
During follow-up visits, readmission for heart failure will be recorded.
Measured: after 6 months of PAB surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Jan 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure CongenitalStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Peking University First Hospital, Beijing Children's Hospital
- Responsible party
- Principal investigator, Shoujun Li, China National Center for Cardiovascular Diseases
- Investigators
- Shoujun Li, MD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039553
- Sponsor's protocol ID
- 2022-1-4032-2
- Status last verified
- Sep 2023
- First submitted
- 9 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Research of Pediatric Heart Failure -- A Self-control Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure
- ClinicalTrials.gov ID
- NCT06039553
- Acronym / sponsor ID
- 2022-1-4032-2
- Conditions
- Heart Failure Congenital
- Keywords
- congenital heart disease, pulmonary artery banding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Peking University First Hospital, Beijing Children's Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Sep 2023 (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 goal of this observational study is to learn about the safety and effectiveness of pulmonary artery banding(PAB) therapy in pediatric heart failure(PHF) patients.
The main questions it aims to answer are:
- Can PAB therapy improve left ventricular(LV) function in PHF patients especially refractory PHF.
- Can the complications caused by the PAB therapy be clinically acceptable? Participants underwent PAB therapy will be required to underwent echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) follow-up before the initiation of PAB and at 1 month, 3 months, and 6 months after PAB surgery. Researchers will compare the LV function 6 months after PAB suergey and the preoperative ones to see if there is improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Artery Banding Group | – | Procedure: pulmonary artery bandingPatient in this group will undergo pulmonary artery banding surgery for congenital heart disease. |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- paitent younger than 14 years of age with heart failure
Key inclusion criteria (2 listed)
- patients younger than 14 years of age
- congenital heart failure (LVEF<55%, or LVFS<25%)
Key exclusion criteria (8 listed)
- single ventricle
- congenital heart disease without anatomical correction
- Patients with heart failure requiring ventricular assist or cardiac synchronization therapy
- Patients with severe pulmonary hypertension (pulmonary arterial pressure >6 Wood·U)
- Patients with severe liver and kidney failure
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 |
|---|---|---|
| pulmonary artery bandingPatient in this group will undergo pulmonary artery banding surgery for congenital heart disease. | Procedure or surgery | Pulmonary Artery Banding Group |
Primary outcome
the recurrence rate of heart failure
Time frame: after 6 months of PAB surgery
During follow-up visits, echocardiographic examination is conducted to measure the left ventricular function. If LVEF falls under 55%, it is recorded as a recurrence.
3 secondary outcomes
NT-proBNP level
Time frame: after 6 months of PAB surgery
Incidence rate of drug adverse reactions
Time frame: after 6 months of PAB surgery
Readmission rate for heart failure
Time frame: after 6 months of PAB surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Shoujun Li, MD study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
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 Heart Failure Congenital, run by China National Center for Cardiovascular Diseases 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 2 inclusion and 8 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 15 Sep 2023. 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 Kai Ma, PhD (+86 15901428497, drmakaifw@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the recurrence rate of heart failure (time frame: after 6 months of PAB surgery). 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 15 Sep 2023.