grant

2/2 Data Coordinating Center for the Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction Study (SPIRRIT-EX)

Organization DUKE UNIVERSITYLocation DURHAM, UNITED STATESPosted 1 Jun 2024Deadline 31 May 2028
NIHUS FederalResearch GrantFY202521+ years oldActive Follow-upAddressAdherenceAdultAdult HumanAgingAldosterone ReceptorAmericanAmericasAsystoleBlindedCardiac ArrestCardiovascularCardiovascular Body SystemCardiovascular DiseasesCardiovascular Organ SystemCardiovascular systemCessation of lifeClinicalClinical ResearchClinical StudyClinical TrialsCountryData AnalysesData AnalysisData Coordinating CenterData Coordination CenterData SourcesDeathDiagnosisDiastolic heart failureDrugsEFRACEjection FractionElementsEnrollmentEnsureEventFundingGuidelinesHF with preserved ejection fractionHFpEFHeart ArrestHeart VascularHeart failureHospital AdmissionHospitalizationIncidenceIndividualInformation DisseminationIntervention TrialInterventional trialInvestigatorsLVEFLeadLeft Ventricular Ejection FractionMedicalMedicationMeta-AnalysisMethodologyMineralocorticoid ReceptorMorbidityMorbidity - disease rateNorth AmericaOutcomeParticipantPatientsPb elementPharmaceutical PreparationsPhonePlacebosPopulationPragmatic clinical trialPrevalencePublic HealthRandomizedRegistriesResearchResearch InstituteResearch PersonnelResearchersRussiaSham TreatmentSouth AmericaSpecific qualifier valueSpecifiedSpirolactoneSpironolactoneSwedenTelephoneTestingTherapeuticTherapeutic InterventionTimeUnited StatesVerospironeactive followupadjudicationadjudicative process and procedureadulthoodantagonismantagonistassess effectivenesscardiac failurecardiovascular disordercare as usualcirculatory systemclinical relevanceclinical trial enrollmentclinical trial participantclinically relevantdata interpretationdata managementdata registrydesigndesigningdetermine effectivenessdissemination of resultsdrug/agenteffectiveness assessmenteffectiveness evaluationenrollevaluate effectivenessevidence baseexamine effectivenessexperiencefollow upfollow-upfollowed upfollowupheart failure and reduced ejection fractionheart failure with preserved ejection fractionheart failure with preserved systolic functionheart failure with reduced ejection fractionheavy metal Pbheavy metal leadimprove symptomintervention therapymortalityparticipant enrollmentpatient enrollmentpragmatic effectiveness trialpragmatic trialpreserved ejection fraction heart failureprimary end pointprimary endpointprimary outcomerandomisationrandomizationrandomized, clinical trialsrandomly assignedsecondary analysissecondary end pointsecondary endpointsecondary outcomesham therapystandard of caresymptom improvementsymptomatic improvementtreatment as usualtrial enrollmentusual care
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Project Summary
Over half of the 6.7 million adults with heart failure in the United States have a normal or near-normal left

ventricular ejection fraction, or heart failure with preserved ejection fraction (HFpEF). The prevalence of HFpEF

is increasing over time, due to ageing of the population and other factors. Morbidity and mortality for…

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2/2 Data Coordinating Center for the Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure | Dev Procure