2015
Use of outcome measures in pulmonary hypertension clinical trials
Parikh KS, Rajagopal S, Arges K, Ahmad T, Sivak J, Kaul P, Shah SH, Tapson V, Velazquez EJ, Douglas PS, Samad Z. Use of outcome measures in pulmonary hypertension clinical trials. American Heart Journal 2015, 170: 419-429.e3. PMID: 26385024, DOI: 10.1016/j.ahj.2015.06.010.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicHemodynamicsHumansHypertension, PulmonaryOutcome Assessment, Health CareConceptsHypertension clinical trialsPulmonary arterial hypertensionPAH trialsClinical practiceInvasive hemodynamicsPrimary endpointClinical trialsOutcome measuresInvasive measuresSurrogate measureDuke University Medical CenterPatient-centered endpointsSecondary outcome measuresClinical treatment trialsMEDLINE/EMBASEUniversity Medical CenterSmall patient populationQuality of lifeContemporary clinical practicePAH therapyPH medicationsArterial hypertensionSerial echocardiographyPatient characteristicsSecondary outcomes
2013
Prognostic Significance of Biomarkers in Predicting Outcome in Patients With Coronary Artery Disease and Left Ventricular Dysfunction
Feldman AM, Mann DL, She L, Bristow MR, Maisel AS, McNamara DM, Walsh R, Lee DL, Wos S, Lang I, Wells G, Drazner MH, Schmedtje JF, Pauly DF, Sueta CA, Di Maio M, Kron IL, Velazquez EJ, Lee KL. Prognostic Significance of Biomarkers in Predicting Outcome in Patients With Coronary Artery Disease and Left Ventricular Dysfunction. Circulation Heart Failure 2013, 6: 461-472. PMID: 23584092, PMCID: PMC3905743, DOI: 10.1161/circheartfailure.112.000185.Peer-Reviewed Original ResearchConceptsCoronary artery bypassPrimary end pointCoronary artery diseaseIndependent prognostic informationArtery bypassMultivariable analysisPrognostic informationSTNFR-1Artery diseaseClinical factorsPlasma levelsUnivariate analysisIschemic Heart Failure (STICH) trialEnd pointSoluble tumor necrosisHeart Failure TrialLeft ventricular reconstructionPrimary outcome variableNet reclassification improvementAbility of biomarkersSubstudy patientsVentricular dysfunctionCardiac hospitalizationBiomarker substudyHeart failure
2011
Circumstances and Outcomes of Sudden Unexpected Death in Patients With High-Risk Myocardial Infarction
Ye S, Grunnert M, Thune JJ, Stephenson KM, Uno H, Finn PV, McMurray JJ, Velazquez EJ, Califf R, Pfeffer MA, Solomon SD. Circumstances and Outcomes of Sudden Unexpected Death in Patients With High-Risk Myocardial Infarction. Circulation 2011, 123: 2674-2680. PMID: 21606398, DOI: 10.1161/circulationaha.110.990655.Peer-Reviewed Original ResearchConceptsHigh-risk myocardial infarctionSudden deathMyocardial infarctionHospital eventsVentricular tachycardia/ventricular fibrillationPrevention of SDSD eventsLong-term mortalityMajority of patientsSudden unexpected deathInitial ECG rhythmCatastrophic complicationUnwitnessed arrestsUnexpected deathVentricular fibrillationTrial trialsPatientsInfarctionECG rhythmDeathPreventionHigher proportionHome eventsArrestSource documentation
2008
Usefulness of Right Ventricular Fractional Area Change to Predict Death, Heart Failure, and Stroke Following Myocardial Infarction (from the VALIANT ECHO Study)
Anavekar NS, Skali H, Bourgoun M, Ghali JK, Kober L, Maggioni AP, McMurray JJ, Velazquez E, Califf R, Pfeffer MA, Solomon SD. Usefulness of Right Ventricular Fractional Area Change to Predict Death, Heart Failure, and Stroke Following Myocardial Infarction (from the VALIANT ECHO Study). The American Journal Of Cardiology 2008, 101: 607-612. PMID: 18308007, DOI: 10.1016/j.amjcard.2007.09.115.Peer-Reviewed Original ResearchConceptsRight ventricular fractional area changeVentricular fractional area changeRight ventricular functionHeart failureFractional area changeMyocardial infarctionClinical outcomesSudden deathCause mortalityVentricular dysfunctionEjection fractionVentricular functionBaseline right ventricular functionRight ventricular systolic functionSevere right ventricular dysfunctionLeft ventricular ejection fractionRecurrent myocardial infarctionRight ventricular dysfunctionLeft ventricular dysfunctionVentricular systolic functionVentricular ejection fractionMajor risk factorTwo-dimensional echocardiogramsCV deathCV outcomes
2006
Previously known and newly diagnosed atrial fibrillation: A major risk indicator after a myocardial infarction complicated by heart failure or left ventricular dysfunction☆
Køber L, Swedberg K, McMurray JJ, Pfeffer MA, Velazquez EJ, Diaz R, Maggioni AP, Mareev V, Opolski G, Van de Werf F, Zannad F, Ertl G, Solomon SD, Zelenkofske S, Rouleau J, Leimberger JD, Califf RM. Previously known and newly diagnosed atrial fibrillation: A major risk indicator after a myocardial infarction complicated by heart failure or left ventricular dysfunction☆. European Journal Of Heart Failure 2006, 8: 591-598. PMID: 16507350, DOI: 10.1016/j.ejheart.2005.11.007.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAgedAngiotensin II Type 1 Receptor BlockersAtrial FibrillationCaptoprilCardiac Output, LowFemaleHumansMaleMiddle AgedMyocardial InfarctionOutcome Assessment, Health CarePrognosisProportional Hazards ModelsRisk AssessmentRisk FactorsSurvival AnalysisTetrazolesTime FactorsValineValsartanVentricular Dysfunction, LeftConceptsAcute myocardial infarctionCurrent atrial fibrillationPrior atrial fibrillationHeart failureAtrial fibrillationRisk of deathMyocardial infarctionCV eventsGreater long-term mortalityMajor CV eventsPrior heart failureAdverse CV eventsMajor cardiovascular eventsVentricular systolic dysfunctionLong-term mortalityHR of deathMajor risk indicatorsCardiovascular eventsSystolic dysfunctionVentricular dysfunctionPrimary outcomeVALIANT trialPatientsLVSDInfarction
2005
Left Ventricular Assessment in Myocardial Infarction: The VALIANT Registry
Hernandez AF, Velazquez EJ, Solomon SD, Kilaru R, Diaz R, O’Connor C, Ertl G, Maggioni AP, Rouleau JL, van Gilst W, Pfeffer MA, Califf RM. Left Ventricular Assessment in Myocardial Infarction: The VALIANT Registry. JAMA Internal Medicine 2005, 165: 2162-2169. PMID: 16217008, DOI: 10.1001/archinte.165.18.2162.Peer-Reviewed Original ResearchConceptsHeart failureMyocardial infarctionLV assessmentCardiac catheterizationVentricular assessmentAcute Myocardial Infarction RegistryAngiotensin-converting enzyme inhibitorClinical heart failureMyocardial Infarction RegistryLeft ventricular functionAcute myocardial infarctionQuality of careHospital mortalityHospital outcomesHospital stayBaseline characteristicsDischarge medicationsVentricular functionMultivariable modelPatientsPropensity analysisEnzyme inhibitorsLower mortalityCatheterizationEchocardiography
2004
Multinational economic evaluation of valsartan in patients with chronic heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT)
Reed SD, Friedman JY, Velazquez EJ, Gnanasakthy A, Califf RM, Schulman KA. Multinational economic evaluation of valsartan in patients with chronic heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT). American Heart Journal 2004, 148: 122-128. PMID: 15215801, DOI: 10.1016/j.ahj.2003.12.040.Peer-Reviewed Original ResearchMeSH KeywordsAdrenergic beta-AntagonistsAgedAngiotensin II Type 1 Receptor BlockersAngiotensin-Converting Enzyme InhibitorsAntihypertensive AgentsCost-Benefit AnalysisDrug Therapy, CombinationFemaleFollow-Up StudiesHealth Care CostsHealth ResourcesHeart FailureHospitalizationHumansMaleMiddle AgedOutcome Assessment, Health CareProportional Hazards ModelsRandomized Controlled Trials as TopicTetrazolesValineValsartanConceptsValsartan Heart Failure TrialHeart failure hospitalizationHeart Failure TrialHeart failureACE inhibitorsFailure hospitalizationFailure TrialNew York Heart Association class IIIncremental costChronic heart failureMean incremental costOutpatient physician servicesBackground therapyCardiovascular medicationsNet incremental costClinical benefitPrescribed therapyClinical signsAmbulance transportationPatientsUnit cost estimatesHealth outcomesPlaceboValsartanClass II