Study of Drug Therapy for Pediatric Heart Failure

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Recruiting

CT.gov ID

NCT06039540

Collaborator

Peking University First Hospital (Other), Beijing Children's Hospital (Other)

200

Enrollment

Location

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Congenital	Drug: Captopril Tablets Drug: Metoprolol Oral Tablet Drug: Spironolactone Tablets Drug: Torsemide Tablets Drug: Potassium citrate powder

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Comprehensive Research of Pediatric Heart Failure--A Prospective Cohort Study of Drug Therapy for Pediatric Heart Failure

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jun 22, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 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
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 0.2-0.5mg/mg, bid Drug: Potassium citrate powder 0.06g/kg, tid

Arm

Intervention/Treatment

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

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

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

0.2-0.5mg/mg, bid

Drug: Potassium citrate powder

0.06g/kg, tid

Outcome Measures

Primary Outcome Measures

the recurrence rate of heart failure [after 6 months of treatment]
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.

Secondary Outcome Measures

NT-proBNP level [after 6 months of treatment]
The trend in NT-proBNP levels.
Incidence rate of drug adverse reactions [after 6 months of treatment]
The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
Readmission rate for heart failure [after 6 months of treatment]
During follow-up visits, readmission for heart failure will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 14 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients younger than 14 years of age
heart failure after congenital heart surgery
Ross > 2 or NYHA > 2
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