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Study of Drug Therapy for Pediatric Heart Failure

NCT06039540 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-09-15

No results posted yet for this study

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

Interventions

DRUG

Captopril Tablets

0.3mg/kg, tid

DRUG

Metoprolol Oral Tablet

0.2mg/kg, bid

DRUG

Spironolactone Tablets

2-4mg/kg, bid

DRUG

Torsemide Tablets

0.2-0.5mg/mg, bid

DRUG

Potassium citrate powder

0.06g/kg, tid

Sponsors & Collaborators

  • Peking University First Hospital

    collaborator OTHER

  • Beijing Children's Hospital

    collaborator OTHER

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Principal Investigators

  • Shoujun Li, MD · Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility

Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-06-22
Completion
2024-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039540 on ClinicalTrials.gov