Evidence map›Paper›PMID 34101002›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2021

Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE.

Li Shen, Brian L Claggett, Pardeep S Jhund, William T Abraham, Akshay Suvas Desai, Kenneth Dickstein, Jianjian Gong, Lars V Køber, Marty P Lefkowitz, Jean L Rouleau and 5 more

3 registry-linked trialsAbstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT00853658 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2015Enrolled7,064ConditionsChronic Heart FailureArmsEnalapril, Aliskiren
NCT01035255 phase3terminatednot on this map

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2014Enrolled8,442ConditionsHeart Failure With Reduced Ejection FractionArmsLCZ696 200 mg BID, Enalapril 10 mg BID
NCT06158711 unknown statusnot on this mapstarted 2023, after this paper: background citation

A Retrospective Study of the Effect of Different Drugs Co-administration in the Treatment of Heart Failure

TypeobservationalSponsorQianfoshan HospitalRan2023 to 2024Enrolled702ConditionsHeart Failure
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Effect of Dapagliflozin Treatment on Index of Cardiac Electrophysiological Balance in Patients With Heart Failure With Reduced Ejection Fraction.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2025
    Article
  5. 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

15 authors.

Li ShenDivision of Medicine, Hangzhou Normal University, Hangzhou, China.
Brian L ClaggettThe Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Pardeep S JhundBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.
William T AbrahamThe Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, Ohio State University, Columbus, USA.
Akshay Suvas DesaiThe Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Kenneth DicksteinStavanger University Hospital, Stavanger, Norway.
Jianjian GongNovartis Pharmaceutical Corporation, East Hanover, NJ, USA.
Lars V KøberRigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.
Marty P LefkowitzNovartis Pharmaceutical Corporation, East Hanover, NJ, USA.
Jean L RouleauInstitut de Cardiologie, Université de Montréal, Montreal, Canada.
Victor C ShiNovartis Pharmaceutical Corporation, East Hanover, NJ, USA.
Karl SwedbergDepartment of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.
Michael R ZileDepartment of Veterans Administration Medical Center, Medical University of South Carolina and RHJ, Charleston, USA.
Scott D SolomonThe Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
John J V McMurrayBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK. john.mcmurray@glasgow.ac.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSudden death (SD) and pump failure death (PFD) are the two leading causes of death in patients with heart failure and reduced ejection fraction (HFrEF).

objectiveIdentifying patients at higher risk for mode-specific death would allow better targeting of individual patients for relevant device and other therapies.

methodsWe developed models in 7156 patients with HFrEF from the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure (PARADIGM-HF) trial, using Fine-Gray regressions counting other deaths as competing risks. The derived models were externally validated in the Aliskiren Trial to Minimize Outcomes in Patients with Heart Failure (ATMOSPHERE) trial.

resultsNYHA class and NT-proBNP were independent predictors for both modes of death. The SD model additionally included male sex, Asian or Black race, prior CABG or PCI, cancer history, MI history, treatment with LCZ696 vs. enalapril, QRS duration and ECG left ventricular hypertrophy. While LVEF, ischemic etiology, systolic blood pressure, HF duration, ECG bundle branch block, and serum albumin, chloride and creatinine were included in the PFD model. Model discrimination was good for SD and excellent for PFD with Harrell's C of 0.67 and 0.78 after correction for optimism, respectively. The observed and predicted incidences were similar in each quartile of risk scores at 3 years in each model. The performance of both models remained robust in ATMOSPHERE.

conclusionWe developed and validated models which separately predict SD and PFD in patients with HFrEF. These models may help clinicians and patients consider therapies targeted at these modes of death. TRIAL REGISTRATION NUMBER: PARADIGM-HF: ClinicalTrials.gov NCT01035255, ATMOSPHERE: ClinicalTrials.gov NCT00853658.

Indexed as

Death, Sudden, CardiacAgedAged, 80 and overBiomarkersFemaleHeart FailureHumansMaleMiddle AgedNatriuretic Peptide, BrainPeptide FragmentsPredictive Value of TestsPrognosisProspective StudiesRandomized Controlled Trials as TopicRisk AssessmentBiomarkersNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)DeviceHeart failureModelPump failure deathRiskSudden death

Identifiers

PMID34101002
PMCPMC8318968

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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.