Evidence map›Paper›PMID 36601956›Full record

Trial reportCirculation. Heart failure2023

Baseline Characteristics of Pediatric Patients With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction in the PANORAMA-HF Trial.

Robert Shaddy, Michael Burch, Paul F Kantor, Susan Solar-Yohay, Tania Garito, Sijia Zhang, Michele Kocun, Damien Bonnet

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Circulation. Heart failure, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02678312 (Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
5.9field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02678312 phase2 / phase3completednot on this map

Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2022Enrolled393ConditionsPediatric Heart FailureArmsLCZ696, Enalapril, Placebo of LCZ696, Placebo of Enalapril
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Pharmacokinetics in the Fontan circulation: a multi-organ puzzle.European heart journal. Cardiovascular pharmacotherapy · 2026
    Review
  4. Article
  5. Management of Pediatric Heart Failure.Korean circulation journal · 2024
    Review
  6. Review
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 5 countries.

Robert ShaddyChildren's Hospital Los Angeles and the Keck School of Medicine of the University of Southern California (R.S., P.F.K.).ORCID 0000-0002-1830-5238
Michael BurchGreat Ormond Street Hospital for Children, London, United Kingdom (M.B.).ORCID 0000-0001-9762-7042
Paul F KantorChildren's Hospital Los Angeles and the Keck School of Medicine of the University of Southern California (R.S., P.F.K.).ORCID 0000-0002-4244-1563
Susan Solar-YohayClinical Drug Development Department, Cardiovascular, Renal, and Metabolism, Novartis Pharmaceuticals, East Hanover, NJ (S.S.-Y., M.K.).ORCID 0000-0002-9998-8359
Tania GaritoNovartis Pharma AG, Basel, Switzerland (T.G.).
Sijia ZhangNovartis, Shanghai, China (S.Z.).ORCID 0000-0001-7057-4921
Michele KocunClinical Drug Development Department, Cardiovascular, Renal, and Metabolism, Novartis Pharmaceuticals, East Hanover, NJ (S.S.-Y., M.K.).ORCID 0000-0002-0608-3623
Damien BonnetM3C-Necker, Congenital and Pediatric Cardiology Department, Necker Hospital-Enfants Malades University Hospital, University of Paris, France (D.B.).ORCID 0000-0002-8722-5805
Novartis (Switzerland) · CHChildren's Hospital of Los Angeles · USGreat Ormond Street Hospital · GBHôpital Necker-Enfants Malades · FRNovartis (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSacubitril/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.

methodsPANORAMA-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).

resultsWe 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.

conclusionsCompared 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.

Indexed as

Heart FailureVentricular Dysfunction, LeftAdolescentAminobutyratesAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsBiphenyl CompoundsChildDrug CombinationsHumansProspective StudiesStroke VolumeTetrazolesTreatment OutcomeValsartanAminobutyratesAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug CombinationssacubitrilTetrazolesValsartanangiotensin receptor antagonistchildrenclinical trialEntrestoheart failureneprilysinventricular dysfunction

Identifiers

PMID36601956
PMCPMC10022669
OpenAlexW4313506820

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.