|
gptkbp:instanceOf
|
gptkb:clinical_trial
|
|
gptkbp:ageRange
|
18 years and older
|
|
gptkbp:allocates
|
randomized
|
|
gptkbp:blinding
|
double-blind
|
|
gptkbp:clinicalTrialPhase
|
Phase III
parallel assignment
|
|
gptkbp:conditionStudied
|
heart failure with reduced ejection fraction
|
|
gptkbp:country
|
multiple countries
|
|
gptkbp:criteria
|
severe renal impairment
history of angioedema
serum potassium >5.2 mmol/L
symptomatic hypotension
|
|
gptkbp:endDate
|
2014
|
|
gptkbp:enrollment
|
8442
|
|
gptkbp:foundIn
|
sacubitril/valsartan superior to enalapril in reducing mortality and morbidity in HFrEF
|
|
gptkbp:fullName
|
gptkb:Prospective_Comparison_of_ARNI_with_ACEI_to_Determine_Impact_on_Global_Mortality_and_Morbidity_in_Heart_Failure
|
|
gptkbp:hasJournal
|
gptkb:New_England_Journal_of_Medicine
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
PARADIGM-HF
|
|
gptkbp:impact
|
led to guideline changes for heart failure treatment
|
|
gptkbp:includes
|
chronic heart failure (NYHA class II-IV), LVEF ≤ 40%
|
|
gptkbp:intervention
|
gptkb:enalapril
gptkb:sacubitril/valsartan
|
|
gptkbp:location
|
global
|
|
gptkbp:mainComparator
|
gptkb:enalapril
|
|
gptkbp:mask
|
double-blind
|
|
gptkbp:participants
|
8442
|
|
gptkbp:principalInvestigator
|
gptkb:John_J.V._McMurray
gptkb:Milton_Packer
|
|
gptkbp:publishedIn
|
McMurray JJ, et al. N Engl J Med. 2014;371(11):993-1004.
|
|
gptkbp:randomizedControlledTrial
|
true
|
|
gptkbp:result
|
cardiovascular death or heart failure hospitalization
sacubitril/valsartan reduced risk of cardiovascular death or heart failure hospitalization compared to enalapril
|
|
gptkbp:safetyOutcome
|
hypotension
renal impairment
hyperkalemia
angioedema risk
|
|
gptkbp:sponsor
|
gptkb:Novartis
|
|
gptkbp:startYear
|
2009
|
|
gptkbp:status
|
completed
|
|
gptkbp:studyType
|
interventional
|
|
gptkbp:trialAcronym
|
gptkb:PARADIGM-HF
|
|
gptkbp:vehicleRegistrationCode
|
gptkb:NCT01035255
|
|
gptkbp:bfsParent
|
gptkb:Entresto
|
|
gptkbp:bfsLayer
|
5
|