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Baseline Characteristics of Pediatric Patients With Heart Failure Due to Systemic Left Ventricular Systolic
Robert Shaddy1, Michael Burch2, Paul F Kantor1
1Children's Hospital Los Angeles and the Keck School of Medicine of the University of Southern California (R.S., P.F.K.).
Insights
The PANORAMA-HF trial evaluated sacubitril/valsartan in pediatric heart failure (HF). This study provides insights into the drug
Area of Science:
- Pediatric Cardiology
- Pharmacology
- Clinical Trials
Background:
- Sacubitril/valsartan is approved for adult heart failure (HF) with reduced ejection fraction.
- The PANORAMA-HF trial investigated its use in pediatric HF patients.
Purpose of the Study:
- To evaluate the pharmacokinetics, pharmacodynamics, efficacy, and safety of sacubitril/valsartan in pediatric HF.
- To compare sacubitril/valsartan with enalapril in children with HF.
Main Methods:
- A multicenter, Phase II/III adaptive, seamless study design.
- 375 pediatric patients were stratified by age and functional classification.
- Patients received sacubitril/valsartan or enalapril for 52 weeks.
Main Results:
- Key demographic and baseline characteristics of 375 pediatric patients were reported.
- Mean ages were 12.2, 3.2, and 1.3 years across age groups.
- Most patients had prior HF hospitalizations and mildly symptomatic HF at baseline.
Conclusions:
- PANORAMA-HF enrolled a homogeneous pediatric HF population across age groups.
- This enables robust evaluation of sacubitril/valsartan's pharmacokinetics/pharmacodynamics and efficacy/safety.
- Most participants had mild HF symptoms at the study's outset.
Background:
Sacubitril/valsartan has been approved for the management of heart failure (HF) with reduced ejection fraction in adults. PANORAMA-HF trial (Prospective Trial to Assess the Angiotensin Receptor Blocker Neprilysin Inhibitor LCZ696 Versus Angiotensin-Converting Enzyme Inhibitor for the Medical Treatment of Pediatric HF) investigated its effects on clinical outcomes in pediatric patients with HF.
Methods:
PANORAMA-HF is a multicenter, Phase II/III study using an adaptive, seamless, 2-part design. The study aimed to evaluate the pharmacokinetics and pharmacodynamics of single doses of sacubitril/valsartan (Part 1), and the efficacy and safety of sacubitril/valsartan versus enalapril administered twice daily for 52 weeks (Part 2) in pediatric patients with HF due to left ventricular systolic dysfunction with biventricular heart physiology. An innovative trial design using a novel global rank assessment of severity was employed. For analysis, eligible patients were stratified into 3 age groups (Group 1, 6 to <18 years; Group 2a, 2 to <6 years; and Group 3a, 1 month to <2 years) and functional classification (New York Heart Association/Ross class I/II and III/IV).
Results:
We report the key demographic, baseline, and clinical characteristics of 375 pediatric patients randomized to receive the study medication. The mean age for patients in Groups 1, 2a, and 3a was 12.2, 3.2, and 1.3 years, respectively. About 70% of patients had a prior HF hospitalization, 85% had New York Heart Association/Ross class I/II HF, and ≈8% were angiotensin-converting enzyme inhibitor/angiotensin receptor blocker naïve.
Conclusions:
Compared to other pediatric HF studies, PANORAMA-HF recruited a relatively homogeneous pediatric HF population across 3 age groups, enabling a more robust evaluation of pharmacokinetics/pharmacodynamics and efficacy/safety of sacubitril/valsartan. Most patients had mildly symptomatic HF at baseline.
Registration:
URL: https://www.
Clinicaltrials:
gov; Unique identifier: NCT02678312.
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