Heart Failure Congenital
Conditions
Keywords
congenital heart failure, drug therapy, congenital heart disease postoperative
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.
Interventions
0.3mg/kg, tid
0.2mg/kg, bid
2-4mg/kg, bid
0.2-0.5mg/mg, bid
0.06g/kg, tid
Sponsors
Peking University First Hospital
Beijing Children's Hospital
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactKai Ma, PhD
Backup ContactZheng Dou, PhD
Outcome results
None listed