Heart Failure

BioLibra

AnaLysIs of Both Sex and Device Specific FactoRs on Outcomes in PAtients with Non-Ischemic Cardiomyopathy

The purpose of this trial is to better understand the outcomes of device-treated ventricular tachyarrhythmias (fast heart beats) and causes of death in non-ischemic cardiomyopathy patients indicated for a BIOTRONIK ICD or CRT D implantation for the primary prevention of sudden cardiac death. The outcomes will be evaluated to determine if there are differences between men and women.


ECG BELT

ECG Belt for CRT Response

This trial is for patients that are planning to have a Medtronic cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator.  The purpose of this study is to compare the management of CRT patients using the ECG Belt Research System along with routine hospital practice.  The Medtronic ECG Belt Research System will be used at some or all of your study visits. If the ECG Belt Research System is used during the implant procedure, it may help to guide where the left heart wire (lead) that connects the CRT to your heart is placed. If the ECG Belt Research System is used during follow-up visits, it may help with adjusting the settings of your CRT system, which may increase your response to the CRT (CRT optimization).

Endurance Trial

The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation. The HeartWare Ventricular Assist System (VAS) is intended for use in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy and who are ineligible for cardiac transplantation. Please contact Jessica Cobb at 352.273.7837 or jessica.cobb@surgery.ufl.edu.


Endurance Supplemental Trial

This trial studies the stroke incidence in patients implanted with a HeartWare┬« HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. Please contact Jessica Cobb at 352.273.7837 or jessica.cobb@surgery.ufl.edu.


MOMENTUM 3

This trial studies the safety and effectiveness of the HeartMate3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure. The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory left ventricular heart failure; either for short term support, such as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long-term support, such as destination therapy (DT). The HM3 is intended for use inside or outside the hospital. Please contact Jessica Cobb at 352.273.7837 or jessica.cobb@surgery.ufl.edu.


Paraglide

A multicenter, randomized, double-blind, double-dummy, parallel group, active controlled study to evaluate the effect of sacubitril/valsartan (LCZ696) versus valsartan on changes in NT-proBNP and outcomes, safety, and tolerability in HFpEF patients with acute decompensated heart failure (ADHF) who have been stabilized during hospitalization and initiated in-hospital or within 30 days post-discharge (PARAGLIDE-HF)

Heart failure occurs when the heart is weak and cannot pump enough blood to your lungs and the rest of your body.  Paraglide HF is for patients that who have been stabilized during hospitalization for acute decompensated heart failure and initiated in-hospital or up to within 30 days post-discharge.

The purpose of this trial is to find out if the study drug, sacubitril/valsartan, is safe and has beneficial effects when added to conventional heart failure therapy in patients with heart failure with preserved ejection fraction who have been stabilized after being admitted to the hospital for new or worsening heart failure.  The trial will assess the effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP and safety and tolerability in patients with HFpEF who have been stabilized during hospitalization for acute decompensated heart failure and initiated in-hospital or up to within 30 days post-discharge.


Transform

ToRsemide comparison with furoSemide FOR Management of Heart Failure (TRANSFORM-HF)

Transform HF is researching whether furosemide or torsemide is best for patients with heart failure. Some clinical information suggests that torsemide may be more beneficial in treating heart failure but more information is needed. This study is being done to compare these two medicines and to determine which is best for patients who have heart failure and were recently admitted to the hospital for acute decompensated heart failure.


Please contact our Clinical Trials Office for information: (352) 273-8933 ufcardiovascularct@medicine.ufl.edu