Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life: The RAMP-IT-UP Multicenter Study

Summary of Objectives Ramp tests are used to optimize left ventricular assist device (LVAD) speed and tailor medical therapy. The addition of invasive hemodynamics to the ramp test has the potential to provide further information that will improve patient management. The aim of this study is to investigate the effects of a hemodynamic-guided approach to LVAD management on clinical outcomes, including exercise capacity and quality of life measures. Methods RAMP-IT-UP is a multi-center, randomized trial comparing two management strategies for LVAD patients: a hemodynamic approach employing a hemodynamic ramp study to optimize LVAD speed and medical therapy (HR arm) and a standard of care approach employing transthoracic echocardiography (TTE) for optimization of LVAD speed and medical therapy (TTE arm). This study enrolled 41 patients (22 in HR arm, 19 in TTE arm) who had an HVAD LVAD and were 1-3 months post-implantation. All patients will be followed for six months after enrollment. Primary endpoints are changes in the 6-minute walk test, New York Heart Association Class and Kansas City Cardiomyopathy Questionnaire score. Exploratory endpoints will include the incidence of clinical events (mortality, heart failure admission, arrhythmias, gastrointestinal bleeding, stroke, pump thrombosis, aortic insufficiency and driveline infection). The analysis will include 6-month results for the full study cohort. The last patient was enrolled in September 2018, and will complete follow-up in March 2019. Endpoints This is the first randomized study of two different clinical management strategies for chronic LVAD patients. This study will evaluate the benefits of a hemodynamic-guided approach on quality of life and outcomes of LVAD patients. (Funded by Medtronic; ClinicalTrials.gov Number, NCT03021239)