2024
Efficacy And Safety Of Sacubitril/valsartan In Patients Hospitalized With Heart Failure: A Prespecified, Pooled Individual Patient-level Analysis Of PIONEER-HF And PARAGLIDE-HF
Morrow D, Velazquez E, Desai A, DeVore A, Lepage S, Park J, Sharma K, Solomon S, Starling R, Ward J, Williamson K, Zieroth S, Hernandez A, Mentz R, Braunwald E. Efficacy And Safety Of Sacubitril/valsartan In Patients Hospitalized With Heart Failure: A Prespecified, Pooled Individual Patient-level Analysis Of PIONEER-HF And PARAGLIDE-HF. Journal Of Cardiac Failure 2024, 30: 312-313. DOI: 10.1016/j.cardfail.2023.10.467.Peer-Reviewed Original ResearchSacubitril/valsartanPIONEER-HFHeart failurePooled analysisNT-proBNPControl therapyDe novo heart failurePlasma NT-proBNP levelsIndependent clinical events committeeIndividual patient-level analysisNovo heart failureNT-proBNP levelsClinical events committeePatient-level analysisCardiovascular deathHemodynamic stabilizationPrimary endpointSymptomatic hypotensionRenal functionMedian ageClinical outcomesRandomized trialsClinical effectsEvents committeeHF events
2023
Angiotensin-Neprilysin Inhibition in Patients With Mildly Reduced or Preserved Ejection Fraction and Worsening Heart Failure
Mentz R, Ward J, Hernandez A, Lepage S, Morrow D, Sarwat S, Sharma K, Starling R, Velazquez E, Williamson K, Desai A, Zieroth S, Solomon S, Braunwald E, Investigators P. Angiotensin-Neprilysin Inhibition in Patients With Mildly Reduced or Preserved Ejection Fraction and Worsening Heart Failure. Journal Of The American College Of Cardiology 2023, 82: 1-12. PMID: 37212758, DOI: 10.1016/j.jacc.2023.04.019.Peer-Reviewed Original ResearchConceptsSacubitril/valsartanEjection fractionWHF eventNT-proBNPSymptomatic hypotensionHeart failureAmino-terminal pro-B-type natriuretic peptideTerminal pro-B-type natriuretic peptidePro-B-type natriuretic peptidePlasma NT-proBNP levelsAngiotensin-Neprilysin InhibitionNT-proBNP changesNT-proBNP levelsUrgent HF visitsChronic heart failureHeart failure eventsLarge treatment effectsHF hospitalizationHF visitsCardiovascular deathPrimary endpointRenal functionClinical benefitNatriuretic peptideWeek 4Sacubitril/valsartan in heart failure with mildly reduced or preserved ejection fraction: a pre-specified participant-level pooled analysis of PARAGLIDE-HF and PARAGON-HF
Vaduganathan M, Mentz R, Claggett B, Miao Z, Kulac I, Ward J, Hernandez A, Morrow D, Starling R, Velazquez E, Williamson K, Desai A, Zieroth S, Lefkowitz M, McMurray J, Braunwald E, Solomon S. Sacubitril/valsartan in heart failure with mildly reduced or preserved ejection fraction: a pre-specified participant-level pooled analysis of PARAGLIDE-HF and PARAGON-HF. European Heart Journal 2023, 44: 2982-2993. PMID: 37210743, PMCID: PMC10424880, DOI: 10.1093/eurheartj/ehad344.Peer-Reviewed Original ResearchConceptsSacubitril/valsartanRenal composite endpointPARAGON-HFHeart failureEjection fractionPooled analysisHF eventsRenal eventsCardiovascular deathComposite endpointLeft ventricular ejection fractionVentricular ejection fractionActive-controlled trialParticipant-level dataPrimary endpointSecondary endpointsClinical outcomesNatriuretic peptideLike patientsTreatment benefitCare settingsPatientsPrimary analysisLVEFValsartanRationale, Design and Baseline Characteristics of the PARAGLIDE-HF Trial: Sacubitril/Valsartan vs Valsartan in HFmrEF and HFpEF With a Worsening Heart Failure Event
Mentz R, Ward J, Hernandez A, Lepage S, Morrow D, Sarwat S, Sharma K, Solomon S, Starling R, Velazquez E, Williamson K, Zieroth S, Braunwald E. Rationale, Design and Baseline Characteristics of the PARAGLIDE-HF Trial: Sacubitril/Valsartan vs Valsartan in HFmrEF and HFpEF With a Worsening Heart Failure Event. Journal Of Cardiac Failure 2023, 29: 922-930. PMID: 36796671, DOI: 10.1016/j.cardfail.2023.02.001.Peer-Reviewed Original ResearchConceptsSac/ValSacubitril/valsartanHeart failure eventsPARAGON-HF trialWHF eventNT-proBNPEjection fractionHeart failureClinical outcomesAmino-terminal pro-B-type natriuretic peptide levelsTerminal pro-B-type natriuretic peptide levelsB-type natriuretic peptide levelsDe novo HFChronic heart failureNatriuretic peptide levelsPrimary efficacy endpointPg/mLEfficacy endpointSafety endpointSecondary endpointsSymptomatic hypotensionBaseline characteristicsRenal functionStable patientsBlack patients
2020
Initiation of Angiotensin-Neprilysin Inhibition After Acute Decompensated Heart Failure
DeVore AD, Braunwald E, Morrow DA, Duffy CI, Ambrosy AP, Chakraborty H, McCague K, Rocha R, Velazquez EJ. Initiation of Angiotensin-Neprilysin Inhibition After Acute Decompensated Heart Failure. JAMA Cardiology 2020, 5: 202-207. PMID: 31825471, PMCID: PMC6990764, DOI: 10.1001/jamacardio.2019.4665.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAgedAminobutyratesAngiotensin Receptor AntagonistsAngiotensin-Converting Enzyme InhibitorsBiphenyl CompoundsDrug CombinationsEnalaprilFemaleHeart FailureHospitalizationHumansMaleMiddle AgedNatriuretic Peptide, BrainNeprilysinPatient DischargePeptide FragmentsTetrazolesValsartanConceptsAcute decompensated heart failureSacubitril/valsartanNT-proBNP levelsDecompensated heart failureOpen-label studyReduced ejection fractionHospital initiationHeart failurePIONEER-HFEjection fractionWeek 8N-terminal pro-B-type natriuretic peptide levelsPro-B-type natriuretic peptide levelsOpen-label extension phaseAngiotensin-Neprilysin InhibitionHeart failure rehospitalizationPIONEER-HF trialWeek 8 visitNatriuretic peptide levelsActive-controlled trialCardiovascular deathComposite outcomeHemodynamic stabilityRecent hospitalizationClinical outcomes
2019
Representativeness of the PIONEER-HF Clinical Trial Population in Patients Hospitalized with Heart Failure
Sayeed S, Fudim M, Xu H, Matsouaka R, Heidenreich P, Yancy C, Fonarow G, Velazquez E, Hernandez A, DeVore A. Representativeness of the PIONEER-HF Clinical Trial Population in Patients Hospitalized with Heart Failure. Journal Of Cardiac Failure 2019, 25: s151. DOI: 10.1016/j.cardfail.2019.07.436.Peer-Reviewed Original ResearchAcute decompensated heart failurePIONEER-HF trialSacubitril/valsartanHFrEF patientsCause mortalityEjection fractionEligible cohortHeart failureLeft ventricular ejection fractionGWTG-HF registryHF rehospitalization ratesDecompensated heart failureReduced ejection fractionInitial study populationVentricular ejection fractionClinical trial populationsLong-term outcomesDaily clinical practiceTrial eligibility criteriaGWTG-HFHF hospitalizationHospital initiationPIONEER-HFHF readmissionIndex dischargeSacubitril/Valsartan Initiated in Black Patients Admitted for Acute Decompensated Heart Failure Reduced NT-proBNP, was Safe and Led to Improved Clinical Outcomes- A Secondary Analysis of the PIONEER-HF Trial
Velazquez E, Ambrosy A, Morrow D, McCague K, Duffy C, O'Brien T, Rocha R, DeVore A, Braunwald E. Sacubitril/Valsartan Initiated in Black Patients Admitted for Acute Decompensated Heart Failure Reduced NT-proBNP, was Safe and Led to Improved Clinical Outcomes- A Secondary Analysis of the PIONEER-HF Trial. Journal Of Cardiac Failure 2019, 25: s80. DOI: 10.1016/j.cardfail.2019.07.227.Peer-Reviewed Original ResearchAcute decompensated HFPIONEER-HF trialHeart failureNT-proBNPBlack patientsPg/mLAngioedema eventsHospital initiationClinical outcomesAcute decompensated heart failureAngiotensin receptor neprilysin inhibitorPre-specified subgroup analysisPrior heart failureACEI/ARBDecompensated heart failureNatriuretic peptide levelsSacubitril/valsartanImproved clinical outcomesSelf-reported raceCV deathEnalapril armHemodynamic stabilizationSymptomatic hypotensionRenal functionNeprilysin inhibitorIn‐hospital initiation of sacubitril/valsartan in acute decompensated heart failure: being in the right place at the right time
Ambrosy AP, DeVore AD, Velazquez EJ. In‐hospital initiation of sacubitril/valsartan in acute decompensated heart failure: being in the right place at the right time. European Journal Of Heart Failure 2019, 21: 1008-1011. PMID: 31218805, DOI: 10.1002/ejhf.1540.Peer-Reviewed Original ResearchCardiovascular biomarkers in patients with acute decompensated heart failure randomized to sacubitril-valsartan or enalapril in the PIONEER-HF trial
Morrow DA, Velazquez EJ, DeVore AD, Prescott MF, Duffy CI, Gurmu Y, McCague K, Rocha R, Braunwald E. Cardiovascular biomarkers in patients with acute decompensated heart failure randomized to sacubitril-valsartan or enalapril in the PIONEER-HF trial. European Heart Journal 2019, 40: 3345-3352. PMID: 31093657, PMCID: PMC6801941, DOI: 10.1093/eurheartj/ehz240.Peer-Reviewed Original ResearchConceptsSacubitril/valsartanAcute decompensated HFAcute decompensated heart failureSoluble ST2Decompensated heart failureHeart failureUrinary cGMPMyocardial stressHigh-sensitivity cardiac troponinCyclic guanosine 3'5PIONEER-HF trialDouble-blind trialReduced ejection fractionMultivariable-adjusted analysesGreater reductionNatriuretic peptide receptorPIONEER-HFCardiovascular deathCardiac afterloadHaemodynamic stabilizationEjection fractionHospitalized patientsMyocardial injuryCardiovascular biomarkersTreatment groupsClinical Outcomes in Patients With Acute Decompensated Heart Failure Randomly Assigned to Sacubitril/Valsartan or Enalapril in the PIONEER-HF Trial
Morrow DA, Velazquez EJ, DeVore AD, Desai AS, Duffy CI, Ambrosy AP, Gurmu Y, McCague K, Rocha R, Braunwald E. Clinical Outcomes in Patients With Acute Decompensated Heart Failure Randomly Assigned to Sacubitril/Valsartan or Enalapril in the PIONEER-HF Trial. Circulation 2019, 139: 2285-2288. PMID: 30955360, DOI: 10.1161/circulationaha.118.039331.Peer-Reviewed Original Research
2018
Rationale and design of the comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode (PIONEER-HF) trial
Velazquez EJ, Morrow DA, DeVore AD, Ambrosy AP, Duffy CI, McCague K, Hernandez AF, Rocha RA, Braunwald E. Rationale and design of the comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode (PIONEER-HF) trial. American Heart Journal 2018, 198: 145-151. PMID: 29653636, DOI: 10.1016/j.ahj.2018.01.004.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAminobutyratesBiphenyl CompoundsCardiac Output, LowCause of DeathDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug CombinationsDrug Delivery SystemsEnalaprilFemaleHeart FailureHumansMaleMiddle AgedNatriuretic Peptide, BrainPatient SafetyPeptide FragmentsPrognosisProspective StudiesRisk AssessmentSeverity of Illness IndexSurvival RateTetrazolesTreatment OutcomeValsartanConceptsAcute decompensated heart failureSacubitril/valsartanB-type natriuretic peptideDecompensated heart failureAmino-terminal pro-B-type natriuretic peptideTerminal pro-B-type natriuretic peptideEjection fractionHeart failureHospital initiationNatriuretic peptideEnd pointClass angiotensin receptor neprilysin inhibitorAngiotensin receptor neprilysin inhibitorPg/Primary efficacy end pointAmbulatory HF patientsExploratory end pointsPIONEER-HF trialEfficacy end pointReduced ejection fractionSafety end pointOpen-label treatmentIncidence of angioedemaYears of agePIONEER-HF