Right ventricular remodeling of severe pulmonary stenosis and pulmonary atresia with intact ventricular septum after PBPV.
Conditions
Interventions
Control group:Placebo
Experimental group:Spironolactone
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children diagnosed with severe PS or PA/IVS by echocardiography after birth; 2. Age =50% reduction in transvalvular pressure gradient; (2) Right ventricular pressure =30 mmHg, or a percentage reduction in right ventricular pressure ((pre-procedure RV pressure - post-procedure RV pressure) / pre-procedure RV pressure) >=40%; (3) Immediate post-procedure echocardiographic measurement shows pulmonary valve transvalvular velocity <3.0 m/s; 4. Obtaining informed consent from the legal guardian (parents or other guardians) and signing a written informed consent form; 5. Children with serum potassium <5.0 mmol/L during the screening period. Note: If serum potassium is between 4.8–5.0 mmol/L, medication may be used cautiously based on clinical judgment and serum potassium levels, and potassium levels should be rechecked after 3 days of medication.
Exclusion criteria
Exclusion criteria: 1. Severe hypotension after surgery requiring continuous vasopressor support (below the 5th percentile for age) or severe systemic hypoperfusion (with progressively increasing lactate >2 mmol/L or persistent oliguria 6 hours), and this condition remains unstable or persists =48 hours before randomization despite active treatment; 2. Pre-enrollment confirmation of liver dysfunction (alanine aminotransferase elevation exceeding 1.5 times the upper limit of normal) or kidney dysfunction (persistent proteinuria, or estimated glomerular filtration rate =5.0 mmol/L, or serum potassium level between 4.8~5.0 mmol/L during the screening period, and after 3 days of treatment, still between 4.8~5.0 mmol/L upon rechecking; 7. Known adrenal cortical hyperplasia or adrenal cortical insufficiency; 8. Right ventricular dependent coronary perfusion; 9. Surgical open-chest intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the extracellular fraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Growth and Nutrition;Serological indicators;Right ventricular structure and function; | — |
Countries
China
Contacts
Public ContactChen Sun
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed