2020 Outcomes - BSW Heart and Vascular Hospital fiscal year 2020 | Page 58

58
Baylor Scott & White Heart and Vascular Hospital Research and Clinical Trials
Dr . McCullough ’ s fifth opinion piece published in late June focused on the collateral damage of the pandemic leading to higher rates of fatal strokes and heart attacks . Titled , COVID-19 has decided to stay and Americans need treatment , the message encourages consideration be given for outpatient treatment guidelines and ability to help recover patients in their own homes .
At the time of printing , an article authored by Dr . McCullough titled Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS- CoV-2 Infection , was accepted by The American Journal of Medicine . This is the first paper to provide guidance to doctors on how to manage COVID-19 patients at home to avoid hospitalization and death .
SOLTERO CARDIOVASCULAR RESEARCH CENTER
The Soltero Cardiovascular Research Center ( SCRC ), a part of Baylor Scott & White Research Institute , began on the Baylor Dallas campus in 1987 . SCRC ’ s goal is to bring clinically relevant cardiology research studies to Baylor Scott & White Health to improve patients ’ lives by understanding , preventing and even reversing heart disease .
Cara East , MD , FAPCR , FACP , FACC , is director of SCRC . SCRC has MAGI Blue Ribbon Site designation and is nationally recognized for conducting high-quality studies on cardiovascular problems , medications and surgical procedures . Its studies have focused on cardiovascular issues caused by diabetes , hardening of the arteries , high blood pressure , and increased levels of lipoprotein molecules in the blood .
SCRC studies open and enrolling in FY20 included :
ALIDIAL – A Phase III trial to evaluate the efficacy and safety of biweekly alirocumab in patients on a stable dialysis regimen . Principal investigator : Cara East , MD .
CLEAR – A randomized , double-blind , placebocontrolled study to assess the effects of bempedoic acid ( ETC-1002 ) on the occurrence of major cardiovascular events in patients with , or at high risk for , cardiovascular disease who are statin intolerant . Principal investigator : Cara East , MD .
DREAM – A double-blind , randomized , shamprocedure-controlled , parallel-group efficacy and safety study of allogeneic mesenchymal precursor cells ( rexlemestrocel-L ) in patients with chronic heart failure due to left ventricular systolic dysfunction of either ischemic or nonischemic etiology : DREAM HF-1 . Principal investigator : Cara East , MD .
EMPEROR-Preserved – A Phase III randomized , double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo , in patients with chronic Heart Failure with preserved Ejection Fraction ( HFpEF ). EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure ( EMPEROR- Preserved ). Principal investigator : Cara East , MD .
EMPEROR-Reduced – A Phase III randomized , doubleblind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo , in patients with chronic Heart Failure with reduced Ejection Fraction ( HFrEF ). EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure ( EMPEROR- Reduced ). Principal investigator : Cara East , MD .
GENETICURE - Association between a multigene panel and renal denervation effectiveness in patients with hypertension ( GxRDxHTN ). An observational study designed to assess whether renal denervation ( RDN ) effectiveness using the Symplicity Spyral™ multi-electrode renal denervation system is associated with ranked genomic scoring from the Geneticure multi-gene algorithm for renal denervation . The study will assess if subjects who have a high genetic score , based on the hypothesized importance of the organ systems involved , will have differential responsiveness to RDN in a descending order . Principal investigator : Cara East , MD .
GUARD – A multicenter , prospective , parallel-group , double-blind , randomized , placebo-controlled , Phase II study of BB3 to assess the safety and efficacy of BB3 in patients developing acute kidney injury after cardiac surgery : The GUARD Study ( Guard Against Renal Damage ). Principal investigator : Robert F . Hebeler , Jr ., MD .
HERITAGE – A multicenter cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein ( a ) levels among patients with established cardiovascular disease . Principal investigator : Cara East , MD .
Lp ( a ) in CVD Patients : Lipoprotein ( a ) in Patients With Cardiovascular Disease – This is a multicenter cross-sectional epidemiological study to estimate the prevalence (%) of patients with elevated Lp ( a ) in patients with established CVD defined by their medical history . Principal investigator : Cara East , MD .
PARADISE – A multicenter randomized , double-blind , active-controlled study to evaluate the effects of LCZ696 ; comparing LCZ696 to ramipril on morbidity