RESEARCH AND CLINICAL TRIALS
RANDOMIZED PLACEBO-CONTROLLED TRIAL OF FCM AS TREATMENT FOR HEART FAILURE WITH IRON DEFICIENCY ( HEART-FID )
Study synopsis : The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous ( IV ) ferric carboxymaltose ( FCM ), relative to placebo , in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction . The placebo-controlled study assesses the effects of IV FCM compared to placebo on the 12-month rate of death , hospitalization for worsening heart failure , and the six-month change in six-minute walk test for patients in heart failure with iron deficiency .
“ This is a national study designed to evaluate the effectiveness and safety of using iron therapy with ambulatory , outpatient heart failure patients who have iron deficiency .”
– Shelley Hall , MD , FACC , FHFSA
Principal investigator ; Chief , Transplant Cardiology , Mechanical Circulatory Support and Heart Failure - Baylor University Medical Center
CLINICAL STUDY TO ASSESS THE EFFICACY AND SAFETY OF MACITENTAN IN PATIENTS WITH PULMONARY HYPERTENSION AFTER LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION ( SOPRANO )
Study synopsis : This study primarily evaluates the effect of macitentan 10 mg on pulmonary vascular resistance ( PVR ) as compared to placebo in subjects with pulmonary hypertension ( PH ) after left ventricular assist device implantation . The study also evaluates the effect of macitentan 10 mg as compared to placebo on cardiopulmonary hemodynamics and disease severity in subjects with PH after LVAD implantation . Finally , the study explores the potential effect of macitentan 10 mg as compared to placebo on right ventricular function , selected clinical events , and on renal function as measured by glomerular filtration rate ( GFR ), in subjects with PH after LVAD implantation .
“ This is an important trial because it may hold great promise for heart failure patients who have pulmonary hypertension and are not currently candidates for heart transplant ,” says Dr . Hall , principal investigator . “ The drug being studied is only approved for treating primary pulmonary hypertension , a disease of the lungs . This study is designed to evaluate heart failure patients with secondary pulmonary hypertension and the effectiveness of treating them with the medication to enable them to hopefully reverse the pulmonary hypertension and ultimately qualify for a heart transplant . For many patients who receive LVADs with no exit strategy to transplant , this trial is of particular interest .”
EVOLVE SHORT DAPT
A prospective study designed to assess the safety of early discontinuation of antiplatelet therapy for patients treated with the Boston Scientific SYNERGY stent .
“ Our stand-out study of 2018 is EVOLVE Short DAPT . Through the hard work of our research staff and participating interventional cardiologists , we were able to finish first out of 120 sites in the world in enrollment .”
– Robert Stoler , MD , FACC , FSCAI
Principal investigator ; Co-Medical Director , Cardiology ; Medical Director , Catheterization Laboratory – Baylor Scott & White Heart and Vascular Hospital - Dallas