Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure

NCT ID: NCT06039553

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Congenital

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary Artery Banding Group

Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.

pulmonary artery banding

Intervention Type PROCEDURE

Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.

Interventions

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pulmonary artery banding

Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients younger than 14 years of age
* congenital heart failure (LVEF\<55%, or LVFS\<25%)

Exclusion Criteria

* 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
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Shoujun Li

Director of Congenital Heart Surgery Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shoujun Li, MD

Role: STUDY_CHAIR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Fuwai hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Ma, PhD

Role: CONTACT

+86 15901428497

Zheng Dou, PhD

Role: CONTACT

+86 18810673618

Facility Contacts

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Shoujun Li, MD

Role: primary

+86 13501071589

Other Identifiers

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2022-1-4032-2

Identifier Type: -

Identifier Source: org_study_id

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