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

September 9, 2023 updated by: Shoujun Li, China National Center for Cardiovascular Diseases

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

paitent younger than 14 years of age with heart failure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pulmonary Artery Banding Group
Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
Procedure: pulmonary artery banding
Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after 6 months of PAB surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NT-proBNP level
Time Frame: after 6 months of PAB surgery
The trend in NT-proBNP levels.
after 6 months of PAB surgery
Incidence rate of drug adverse reactions
Time Frame: after 6 months of PAB surgery
The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
after 6 months of PAB surgery
Readmission rate for heart failure
Time Frame: after 6 months of PAB surgery
During follow-up visits, readmission for heart failure will be recorded.
after 6 months of PAB surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

Peking University First Hospital
Beijing Children's Hospital

Investigators

  • Study Chair: Shoujun Li, MD, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 9, 2023

First Submitted That Met QC Criteria

September 9, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 9, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1-4032-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure Congenital

Clinical Trials on pulmonary artery banding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe