Study of Drug Therapy for Pediatric Heart Failure

NCT06039540 | Unknown FDA Drug

• 1 other identifier: 2022-1-4032-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric heart failure patients. The main questions it aims to answer are:

• Can a modified drug therapy improve left ventricular function in pediatric heart failure patients?
• Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a 6-months course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 1 month, 3 months, and 6 months after treatment commencement. Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of treatment, is lower in the former than in the latter.

Conditions

Heart Failure Congenital

Keywords

congenital heart failure; drug therapy; congenital heart disease postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  after 6 months of treatment

Secondary Outcomes (3)

• NT-proBNP level

  after 6 months of treatment

• Incidence rate of drug adverse reactions

  after 6 months of treatment

• Readmission rate for heart failure

  after 6 months of treatment

Study Arms (2)

Modified Drug Therapy Group

Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/ mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).e Traditional Drug Therapy Group

Drug: Captopril Tablets; Drug: Metoprolol Oral Tablet; Drug: Spironolactone Tablets; Drug: Torsemide Tablets; Drug: Potassium citrate powder

Traditional Drug Therapy Group

Patient in this group will undergo a one-year course of medication, including Torsemide(tablet, 0.2-0.5mg/mg, bid) and Potassium Citrate(powder, 0.06g/kg, tid).

Drug: Torsemide Tablets; Drug: Potassium citrate powder

Interventions

Captopril Tablets DRUG

0.3mg/kg, tid

Modified Drug Therapy Group

Metoprolol Oral Tablet DRUG

0.2mg/kg, bid

Modified Drug Therapy Group

Spironolactone Tablets DRUG

2-4mg/kg, bid

Modified Drug Therapy Group

Torsemide Tablets DRUG

0.2-0.5mg/mg, bid

Modified Drug Therapy Group; Traditional Drug Therapy Group

Potassium citrate powder DRUG

0.06g/kg, tid

Modified Drug Therapy Group; Traditional Drug Therapy Group

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

paitent younger than 14 years of age with heart failure after suergry congenital heart disease

You may qualify if:

• Patients younger than 14 years of age
• heart failure after congenital heart surgery
• Ross \> 2 or NYHA \> 2
• LVEF\<55%, or LVFS\<25%

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Peking University First Hospital: collaborator
• Beijing Children's Hospital: collaborator

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Interventions

Captopril; Metoprolol; Spironolactone; Torsemide

Intervention Hierarchy (Ancestors)

Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Lactones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shoujun Li, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Central Study Contacts

Kai Ma, PhD

CONTACT

+86 15901428497; drmakaifw@yahoo.com

Zheng Dou, PhD

CONTACT

+86 18810673618; drdouzheng@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Congenital Heart Surgery Center

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: September 15, 2023
• Study Start: January 1, 2022
• Primary Completion: June 22, 2024
• Study Completion: December 31, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)