Clinical trial NCT06039540: Study of Drug Therapy for Pediatric Heart Failure
Official title: A Comprehensive Research of Pediatric Heart Failure--A Prospective Cohort Study of Drug Therapy for Pediatric Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure Congenital
Keywords: congenital heart failure
drug therapy
congenital heart disease postoperative
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Peking University First Hospital
name: Beijing Children's Hospital
First posted: 2023-09-15
Enrollment: 200
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: paitent younger than 14 years of age with heart failure after suergry congenital heart disease

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.


Eligibility criteria: 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

Primary outcomes:
measure: the recurrence rate of heart failure
timeFrame: after 6 months of treatment
Secondary outcomes:
measure: NT-proBNP level
timeFrame: after 6 months of treatment
measure: Incidence rate of drug adverse reactions
timeFrame: after 6 months of treatment
measure: Readmission rate for heart failure
timeFrame: after 6 months of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shoujun Li, MD
role: STUDY_CHAIR
References: