Heart FailureNCT06345521
Etablishment of Follow-up System and End-Stage Heart Registration Platform for Pediatric Heart Failure
An observational study of Heart Failure and Congenital, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Establish a follow-up management system for pediatric heart failure and a registration platform for end-stage heart failure Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Heart Failure, Congenital, End-stage Heart Failure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- 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
- No healthy volunteers
- Child
Study population: Children with end-stage heart failure
Who may be able to join
- Patients younger than 14 years of age
- refractory heart failure
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai hospital
Beijing
Shoujun Li, MD, +86 13501071589, drlishoujunfw@163.com
About this study
Official title: A Comprehensive Research of Pediatric Heart Failure-- Etablishment of Follow-up System and End-Stage Heart Registration Platform for Pediatric Heart Failure
Establish a follow-up management system for pediatric heart failure and a registration platform for end-stage heart failure
- Conditions
- Heart Failure, Congenital, End-stage Heart Failure
- Being tested
- No intervention
- Keywords
- Congenital Heart Failure, Registry, End-stage Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| End-Stage Heart Failure Group | Children with end-stage heart failure Receives: Other: No intervention |
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: 6 months
Secondary outcomes (3)
NT-proBNP level
The trend in NT-proBNP levels.
Measured: 6 months
Incidence rate of drug adverse reactions
The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
Measured: 6 months
Readmission rate for heart failure
During follow-up visits, readmission for heart failure will be recorded.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jan 2022
- Primary completion22 Jun 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 FailureStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Peking University First Hospital, Beijing Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Shoujun Li, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345521
- Sponsor's protocol ID
- 2022-1-4032-3
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2024
- Last updated
- 28 May 2024
- 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 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Research of Pediatric Heart Failure-- Etablishment of Follow-up System and End-Stage Heart Registration Platform for Pediatric Heart Failure
- ClinicalTrials.gov ID
- NCT06345521
- Acronym / sponsor ID
- 2022-1-4032-3
- Conditions
- Heart Failure, Congenital, End-stage Heart Failure
- Keywords
- Congenital Heart Failure, Registry, End-stage Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 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
- 22 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Apr 2024 (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.
Establish a follow-up management system for pediatric heart failure and a registration platform for end-stage heart failure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End-Stage Heart Failure Group | – | Other: No interventionChildren with end-stage heart failure |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with end-stage heart failure
Key inclusion criteria (2 listed)
- Patients younger than 14 years of age
- refractory heart failure
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| No interventionNo intervention | Other | End-Stage Heart Failure Group |
Primary outcome
the recurrence rate of heart failure
Time frame: 6 months
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: 6 months
Incidence rate of drug adverse reactions
Time frame: 6 months
Readmission rate for heart failure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- 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 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 and 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 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 28 May 2024. 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: 6 months). 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 28 May 2024.