Heart failure & cardiomyopathiesRandomised controlled trial
Sacubitril/Valsartan in Pediatric Heart Failure (PANORAMA-HF): A Randomized, Multicenter, Double-Blind Trial
- Randomised controlled trial
- double-blind
- multicentre
Authors' conclusion
In this study, sacubitril/valsartan did not show superiority over enalapril in the treatment of children with HF attributable to systemic LVSD using the prespecified global rank end point. However, both treatment arms showed clinically meaningful improvements over 52 weeks.
Study context
- Population
- Children 1 month to <18 years with heart failure (HF) attributable to systemic LV systolic dysfunction
- Participants
- 375 children
- Comparison
- Sacubitril/valsartan vs enalapril
- Sacubitril/valsartann = 187
- Enalapriln = 188reference
- Primary endpoint
- Global rank end point:
- Death
- Listing for urgent heart transplant
- Mechanical life support
- Worsening HF
- NYHA/Ross class
- PGIS
- PedsQL physical functioning
- Follow-up
- 52 weeks
Primary result
As reported in the abstract
Global rank end point · week 52
- Sacubitril/valsartan
- Mann-Whitney probability 0.52 (95% CI 0.47–0.58); P = 0.42
- Sacubitril/valsartan
- Mann-Whitney odds 0.91 (95% CI 0.72–1.14); P = 0.42
Further findings
New York Heart Association (NYHA)/Ross, Patient Global Impression of Severity (PGIS), Patient Global Impression of Change, NT-proBNP · week 52
- Clinically meaningful reductions in both arms, without significant differences between groups
- NT-proBNP change an exploratory end point
Safety
Adverse events
Adverse events
- Adverse events similar between arms; safety profile of sacubitril/valsartan acceptable in children
Original publication
Sacubitril/Valsartan in Pediatric Heart Failure (PANORAMA-HF): A Randomized, Multicenter, Double-Blind Trial. Circulation. Published 25 September 2024. doi:10.1161/circulationaha.123.066605
Summarised from the published abstract; every number is checked against it