2020
Efficacy of Tafamidis in Transthyretin Amyloid Cardiomyopathy in the ATTR-ACT Trial
Berk J, Damy T, Drachman B, Elliott P, Gottlieb S, Grogan M, Gundapaneni B, Hanna M, Hoffman J, Hummel S, Judge D, Lenihan D, Merlini G, Patterson T, Rapezzi C, Schwartz J, Shah S, Sultan M, Velazquez E, Cruz M, Witteles R. Efficacy of Tafamidis in Transthyretin Amyloid Cardiomyopathy in the ATTR-ACT Trial. Heart & Lung 2020, 49: 209-210. DOI: 10.1016/j.hrtlng.2020.02.009.Peer-Reviewed Original ResearchEfficacy of tafamidisSix-minute walk distanceATTR-CMCause mortalityQuality of lifeWalk distanceHeart failureKansas City Cardiomyopathy Questionnaire overall scorePre-specified sensitivity analysisSix-minute walk test distanceTransthyretin Cardiomyopathy Clinical TrialHard cardiovascular endpointsFirst-line therapyKey secondary endpointPrimary efficacy analysisTransthyretin amyloid cardiomyopathyOverall scoreMechanical assist devicesClinical laboratory testsNovel study designNYHA classTafamidis groupPlacebo groupSecondary endpointsAdverse events
2015
Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction
Redfield MM, Anstrom KJ, Levine JA, Koepp GA, Borlaug BA, Chen HH, LeWinter MM, Joseph SM, Shah SJ, Semigran MJ, Felker GM, Cole RT, Reeves GR, Tedford RJ, Tang WH, McNulty SE, Velazquez EJ, Shah MR, Braunwald E. Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. New England Journal Of Medicine 2015, 373: 2314-2324. PMID: 26549714, PMCID: PMC4712067, DOI: 10.1056/nejmoa1510774.Peer-Reviewed Original ResearchConceptsHeart failureEjection fractionIsosorbide mononitratePlacebo groupDose regimensWalk distanceLife scoresN-terminal pro-brain natriuretic peptidePro-brain natriuretic peptideEnd pointSignificant between-group differencesIsosorbide mononitrate groupLow daily activityNT-proBNP levelsPrimary end pointSecondary end pointsSubmaximal exercise capacityDose-escalation regimenHours of activityActivity levelsBetween-group differencesDaily activity levelsDaily activitiesActivity toleranceExercise capacity
2013
Low-Dose Dopamine or Low-Dose Nesiritide in Acute Heart Failure With Renal Dysfunction: The ROSE Acute Heart Failure Randomized Trial
Chen HH, Anstrom KJ, Givertz MM, Stevenson LW, Semigran MJ, Goldsmith SR, Bart B, Bull DA, Stehlik J, LeWinter MM, Konstam MA, Huggins GS, Rouleau JL, O'Meara E, Tang WH, Starling RC, Butler J, Deswal A, Felker GM, O'Connor CM, Bonita RE, Margulies KB, Cappola TP, Ofili EO, Mann DL, Dávila-Román VG, McNulty SE, Borlaug BA, Velazquez EJ, Lee KL, Shah MR, Hernandez AF, Braunwald E, Redfield MM. Low-Dose Dopamine or Low-Dose Nesiritide in Acute Heart Failure With Renal Dysfunction: The ROSE Acute Heart Failure Randomized Trial. JAMA 2013, 310: 2533-2543. PMID: 24247300, PMCID: PMC3934929, DOI: 10.1001/jama.2013.282190.Peer-Reviewed Original ResearchConceptsLow-dose dopamineAcute heart failureCumulative urine volumeRenal dysfunctionCystatin C levelsHeart failureRenal functionUrine volumeDiuretic therapyPlacebo-controlled clinical trialEnd pointPooled placebo groupCoprimary end pointsSecondary end pointsHours of admissionC levelsSerum cystatin CDose dopaminePlacebo groupActive treatmentClinical outcomesRandomized trialsClinical trialsCystatin CMAIN OUTCOME